Tag Archive for 'Recall'

Weekly Highlights (2/22/2012)

Published on February 22, 2012 in News. 4 Comments Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , .

We hope you had a fantastic long weekend! This week’s highlights was delayed a bit so I could devote some time to the arsenic and rice news that came out late last week. Here’s a little more of what I’ve been reading this past week. - Jasmine

In the News:

Johnson & Johnson Recalls Infant’s Tylenol - In case you missed it on our Facebook page, Johnson & Johnson has issued a nationwide recall of all infant tylenol on the market due to reported difficulties using the new dosing syringe.

You may recall that manufacturers of infant’s tylenol were in the process of changing the concentrations and dosing systems to make administering easier and safer. Unfortunately, back to the drawing board for J&J.

No adverse events have been reported, but if you’d like a refund you can visit their website or call for a refund. Consumers can still use the product if the flow restrictor remains in place. The instructional video below issued by McNeil demonstrates how to use the syringe.

Maine Groups Press for BPA Ban After Chemical Found in Baby and Toddler Food - 11 out of 12 major brands of jarred baby food tested positive for BPA in the lids, and tests also showed that the BPA had been found in the baby food. Levels were 1 to 3 parts per billion, but the physiology professor cited in the article says that’s enough to be concerned. Levels in toddler canned foods were found up to 134 parts per billion. Just one of the many reasons I chose to make my own baby food. If you’re interested, you can find tips here: Homemade Baby Food - As Easy as 1-2-3.

EPA Issues Long-Awaited Dioxins Report - After working on the report for decades, the EPA has released the first half of its assessment on the toxicity of dioxins, the most toxic of all man-made chemicals. The first release addresses the noncancerous effects, while the second half of the report is expected to address evidence of the chemical’s cancerous effects.

While the report concludes that dioxins are seriously toxic at low levels, it says that exposures have declined so much over the past few decades that most people should not be concerned. As one scientist put it, though, that statement is “very odd” as it ignores people who are exposed to higher levels or more sensitive to the effects, like fetuses and young children.

FDA Will Not Allow More Fungicide in Orange Juice - Back in January, the FDA halted imports of orange juice and began inspecting them after they received notification that Brazilian growers had been using a U.S.-banned fungicide. Now Brazil has requested an exception for the fungicide until they can phase it out, but the FDA has denied the exception. As a result, Brazil will have to stop exports of concentrated OJ until they can meet EPA limits for the fungicide.

New Research:

BPA’s Obesity And Diabetes Link Strengthened By New Study 
To date, studies have suggested a link between BPA and metabolic problems, but no one was really sure why until now. A new study released last week has determined that BPA fools a specific receptor into thinking that it is estrogen, an insulin regulator, and triggers the release of almost double the insulin actually needed to break down food. When that specific receptor was removed from the subject mice, the effect disappeared.

According to the author of the study, Angel Nadal, “When you eat something with BPA, it’s like telling your organs that you are eating more than you are really eating.” And surprisingly, the effects were seen at very low levels of exposure - a quarter of a billionth of a gram was enough to do the trick. What is most concerning is the impact on pregnant women and developing fetuses, who are particularly sensitive - ”The fetus is not only exposed to BPA but also to higher levels of insulin from the mother, making the environment for the fetus even more disruptive,” says Nadal. “This is a very delicate period.”

Children at Risk for Ingestion of PAHs from Pavement Sealant
Coal tar sealants, commonly used in the Central, Southern, and Eastern U.S. to refresh driveways and parking lots, are a source of polycyclic aromatic hydrocarbons, some of which can cause cancer. Researchers from Baylor University and the U.S. Geological Survey have found that children living next to driveways or parking lots coated with coal tar are exposed to 14 times the amount of the chemicals than those living near untreated asphalt. Exposure is primarily through contaminated dust tracked into the home, rather than food as once thought. Coal-tar-based pavement sealant has PAH concentrations 100 to 1,000 times greater than most other sources.

A History of Kids and Sleep: Why They Never Get Enough
I wouldn’t say that the article explains why children never get enough, but a recent review of about 300 studies on sleep duration in children found some interesting results:

  • Over the 112 years the study covered, age-specific recommendations for sleep and actual sleep duration of children has declined at similar rates.
  • Over that same period, children have lost about 75 minutes of shut-eye with overstimulation and modern technology to blame.
  • There’s not much evidence behind sleep recommendations; they’re pretty subjective. Kids consistently get at least 30 minutes less than the recommendations.
  • Different countries have different standards, but American children sleep less than nearly all other children.

Fantastic Finds:

How to Get Rid of Facebook Timeline, Bring Back a Simpler View - Anyone else struggling to get used to the new timeline view? It seems cluttered and messy to me. LifeHacker just published an article with a plugin that can be used to adjust your browser’s Facebook view for a cleaner look. I’m definitely going to try this out.

Clean Protein & Organic Foods, Does it Matter? - An absolutely fascinating read on why it’s important to look beyond the organic label and really understand where your food came from and how it was raised.

4 Health Reasons to Eat Chocolate (and Cons to Consider) - With Valentine’s Day behind us and chocolate floating around the house, this article is timely and informative.

From Playdate to Parliament: Mom Takes Tot to Work - Adorable. Little Victoria Ronzulli conducts important business at the European Parliament alongside mother and Italian politician, Licia Ronzulli.

Recalls, February 14 – February 21:

CPSC Child Product Recalls

Child Safety Seat Recalls

No child safety seat recall announcements this week.

USDA/FDA Recalls

If there’s anything you see and think we should feature, please send it to jasmine@purebebe.com.

FluZone Vaccine Recall Nothing to Worry About

Published on January 9, 2012 in Vaccines. 0 Comments Tags: , , , , , , , , .

Last week, the FDA posted notice of what appeared to be a recall of Sanofi Pasteur’s FluZone. The notice indicated that the vaccine was misbranded “due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine”.

There has been some buzz about it online, so I reached out to my pediatrician for more information. Upon calling my pediatrician, I was informed that the recall was not in fact a recall but simply a notice sent to doctors of a reprinting of the package insert due to a transcription error on page 8 of the insert. The vaccine has not been recalled, and the recall notice does not impact the dosage, safety or effectiveness of the vaccine.

So if you or your child received the FluZone vaccine, rest assured that it has not been recalled.

 

The notice posted on the FDA’s recall page is reproduced below:

PRODUCT
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5 mL, NDC 49281-011-10. Recall # B-0460-12

CODE
Lot numbers U4114DA, exp 6/30/12; U4118AA, exp 6/30/12; U4118BA, exp 6/30/12; U4118BB, exp 6/30/12; U4122AA, exp 6/30/12; U4122BA, exp 6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12; U4124BA, exp 6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp 6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp 6/30/12; U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp 6/30/12; and U4197AB, exp 6/30/12

RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA, by letter on November 14, 2011. Firm initiated recall is ongoing.

REASON
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5mL, misbranded due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine, was distributed.

VOLUME OF PRODUCT IN COMMERCE
2,832,810 units

DISTRIBUTION
Nationwide

Weekly Highlights (12/26/2011)

Published on December 26, 2011 in News. 2 Comments Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , .

We hope you had a wonderful holiday weekend!

Welcome to “Weekly Highlights”, our weekly post that recaps important child health and safety news, research, and recalls from the previous week and other great finds we’ve come across in our internet travels.

In the News:

Mead Johnson Retests Samples of Enfamil and Reaffirms Safety - The company completed a second round of testing on samples of its Enfamil Newborn formula from the batch under recall. The tests showed no signs of the bacteria, but tests results from federal health officials will not be in until later this week. Check enfamilalerts.com or our sidebar for updates.

Two Strengths of Infant Acetaminophen Boost Confusion, Risk - Old and new infant formulations are currently on shelves with some even mislabeled. Be sure to check the concentration and dosage amounts, particularly for infants under 2.

EPA Issues Historic Regulations on Air Pollution - New rules issued this week by the EPA, overdue by about 20 years, will dramatically reduce mercury levels as well as other toxins from coal power plants, resulting in a significant reduction in premature births, childhood asthma, bronchitis, and other related illnesses, the EPA estimates.

Retailer Blames China Suppliers as More Jewelry Recalled- Health Canada’s recall blitz this week caught jewelry imported from China with levels of lead up to 86% and cadmium up to 46%.

New Research:

Studies Suggest an Acetaminophen-Asthma Link
Evidence is mounting of a possible link between acetaminophen use in infants and the development of childhood asthma. One study in 2008 found that children under 1 who had taken acetaminophen for a fever had a 50% greater risk of developing asthma symptoms. A single dose can reduce the body’s levels of a peptide that helps prevent inflammation in the airways. Yet, researchers still say it is difficult to determine whether the acetaminophen or the infection are to blame. The doctor quoted in the article suggests reserving acetaminophen only for very high fevers and major pain relief.

How Toddlers Hear Themselves
Ever wonder why toddlers can’t seem to pronounce certain words just right? 2 year olds do not listen to themselves and self-correct like adults do. They focus on the content of what they are saying rather than how they say it, which is why when you repeat back to a child what you think they said (pronounced correctly) they will say “yes”. Starting around age 3, children begin to develop the ability to repair conversations. Be a good speech model and focus on what your children are saying rather than correcting how they say it.

Fantastic Finds:

How to Get Your Favorite Fruits in the Winter from CNN Health - A guide to the choosing the tastiest and healthiest fruits in the winter.

Riley on Marketing from YouTube - One little girl expresses her frustration at gender-biased marketing. High five!

Recalls, December 20 – December 26:

CPSC Child Product Recalls

Child Safety Seat Recalls

No child safety seat recall announcements this week.

USDA/FDA Recalls

If there’s anything you see and think we should feature, please send it our way to jasmine@purebebe.com. We hope your week is off to a great start!

XOXO,
Jasmine & Heather

Statement from Mead Johnson on Enfamil Formula Recall

Published on December 22, 2011 in Recalls. 0 Comments Tags: , , , , , , , , , , , , .

Mead Johnson has issued the following statement on its website, enfamilalerts.com, in response to the Enfamil recall today:

Statement from Mead Johnson on Enfamil PREMIUM® Newborn Formula Safety

December 22, 2011

Our company recently became aware of an infant’s death in Missouri. This infant tested positive for Cronobacter, which is a microorganism commonly found in the environment and sometimes implicated in rare but serious illnesses in newborn babies. We were informed that the infant had been fed one of our products.

The product – Enfamil PREMIUM® Newborn powdered formula – has not been recalled, but is being tested by the U.S. Food and Drug Administration (FDA) with our assistance. All of our finished infant powdered products (including this batch) are tested for Cronobacter (Enterobacter sakazakii) prior to shipment. If an ingredient or a batch of powdered infant formula product is found to contain Cronobacter, it is rejected and not distributed.

The batch of the product used by the child’s family did not show the presence of the bacteria when it was produced and packaged, and that has recently been reconfirmed from our batch records. This product is not being recalled – nor is any other Mead Johnson product – but some retailers are removing it from their shelves as a precautionary measure. The product is Enfamil PREMIUM Newborn 12.5 ounce powder with number ZP1K7G on the bottom of the can.

We recognize that recent media stories may cause confusion and we apologize for that. We want to make every effort to keep our customers informed on any topics related to our products.

We are working with health authorities to support their efforts to identify the source or cause of the infant’s infection. All the employees at Mead Johnson Nutrition wish to extend our heartfelt sympathy to the family.

If you have any questions please contact us at 1-800-BABY-123.

Walmart Issues Recall of Powdered Enfamil Formula After Infant Dies

Published on December 22, 2011 in Food, Health & Safety and Recalls. 6 Comments Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , .

Walmart has issued a nationwide recall of Enfamil Premium Newborn powdered formula after a 10-day old baby boy died in Missouri, and another Missouri infant was hospitalized with the same bacterial infection.

The recalled formula comes in 12.5 oz cans with lot number ZP1K7G. It is unclear whether other retailers may have the same lot on their shelves.

The bacteria, called “Enterobacter sakazakii,” or E. sakazakii for short, occasionally appears in infant formula. No known cases of E sakazakii have been found in exclusively breastfed infants.

Health officials with the CDC and FDA are investigating samples of formula and distilled water used by the parents to prepare the formula but have not yet called for an Enfamil recall. It could be several days before the results are in, but milk-based powdered infant formulas have been implicated in prior outbreaks of this bacteria.

Mead Johnson, maker of the formula, says that the batch used by the infant’s family tested negative for the bacteria when it was produced and packaged, and they are working with health officials to identify the source of the bacteria. Meanwhile, Walmart is taking no risks and has pulled the product from shelves and is recalling purchased cans. Any customer who has purchased the recalled formula may return it to the store for a full refund or exchange for another brand. Customers may also call 1-800-BABY-123 for more information.

To read more about this bacteria and powdered formula recall:
Wal-Mart pulls formula after Mo. baby’s death
Walmart Recalls Enfamil Infant Formula After Baby Dies

Updates:

Walgreens, Kroger, Supervalu Restock Formula – 1/4/2012
FDA Says No Need to Recall Enfamil Formula - 12/31/2011
14 U.S. Commissaries Pull Formula – 12/30/2011
FDA Visits Mead Johnson Factory as Part of Continuing Investigation – 12/28/2011
Oklahoma Baby 3rd Sickened by Rare Bacteria – No Link to Enfamil – 12/28/2011
Commissary Recalls Baby Formula Amid Bacteria Tests – 12/28/2011
Parents of Another Sick Child Fear Enfamil Formula May Be The Cause – 12/26/2011 Mead Johnson Says New Tests Did Not Detect Cronobacter – 12/25/2011
Walgreen, Kroger, and Safeway Pull Formula – 12/23/2011
Price Chopper Supermarkets Voluntarily Recall Enfamil - 12/23/2011
Enfamil Recall: More Retailers Pull It Off Shelf (Supervalu) - 12/22/2011

New Crib Safety Standards: Q&A from the CPSC

Published on March 10, 2011 in Recalls and Sleep. 4 Comments Tags: , , , , , , , , .

image courtesy pierrotsomepeople,flickr.com

Last year, the government issued new crib safety standards, replacing standards that had not been updated in nearly 30 years. Since 2007, the CPSC had recalled more than 11 million cribs, most of which have been drop-side cribs. Detaching drop-side cribs have been associated with at least 32 infant suffocation and strangulation deaths since 2000. The new crib standards now ban the manufacture and sale of drop-side cribs. Other provisions included in the standards will require stronger mattress supports, more durable hardware, and more rigorous safety testing.

The new standards will be effective in June of this year for all cribs manufactured, sold, or rented in the U.S. As this date approaches, the CPSC has received a number of questions on the new standards and in response, they issued a Q&A on their blog, OnSafety, last week. If you have a child in a crib or are planning to purchase a crib, it’s worth a read. If your child will be growing out of their crib soon and you’re thinking about selling or donating it, the new standards will apply to you too. Below are a few of the highlights:

  • The new crib standards are effective June 28, 2011 and apply to all cribs, used and new, sold in the U.S.
  • New cribs may be available for purchase before June 28th, but you’ll need to ask the retailer or manufacturer whether the crib you are considering meets the new standards.
  • Traditional drop-side cribs will not meet the new standards. You may be able to obtain an immobilizer from the manufacturer or retailer to secure the drop-side, but it will still not meet the requirements.
  • The CPSC has issued the following recommendations if you have a traditional drop-side crib and you continue to use it:
    • Check CPSC’s crib recall list to see if it has been recalled.
    • Check the crib frequently to make sure all of the hardware is secured tightly and that there are no loose, missing, or broken parts.
    • If your crib has a drop-side rail, stop using that drop-side function and request an immobilizer if available. Immobilizers will vary depending on the crib.
    • Consider another option such as a portable play yard, so long as it has not been recalled.
  • If you decide to stop using your crib, drop-side or not, you cannot sell or donate a crib that does not meet the new standards. Instead, the CPSC says you should disassemble it and discard it.
  • All daycare facilities, home daycares, and places of accommodation like hotels and motels have until December 28, 2012 to be compliant with the new standards.

You may be asking yourself, how do I know if my crib meets the new standards? Unfortunately, I don’t think you’ll be able to determine that. The details of the rules issued by the CPSC have this to say in response to a comment submitted which asked if they would provide a method of checking whether current cribs meet the new standards:

“Because the crib would be destroyed in the process of testing, it is impossible to test each crib. Therefore, we cannot provide methods to check existing cribs for compliance with the CPSC’s new crib standards. We also note that retrofits that would be appropriate for a recall might not be sufficient to meet the requirements of the new standards.”

There goes the resale market! My 1 year old is currently in a drop-side crib. For the near term, we plan to continue to use it and check it frequently and then discard it when she moves up into a big girl bed. If you have a drop-side crib, what do you plan to do?

Perhaps you can do what this resourceful owner did…

Drop-side crib upcycled into a compost bin; image courtesy NineInchNachos9, flickr.com

 

-Jasmine

Related Articles:
Massive Crib Recall Announced: What You Should Know
Creating a Safe Sleep Environment for Baby
Rest Easy with an Organic Mattress
Fantastically Funny Friday (2/25/2011) – Brilliant Baby

Jogging Strollers Recalled Due to Strangulation Hazard – B.O.B. Trailers

Published on February 28, 2011 in Baby Gear. 4 Comments Tags: , , , , , .

Two weeks ago, I was out shopping with my two daughters.  I had them both strapped into our B.O.B. Revolution double stroller. While I was speaking to a sales associate, my eldest daughter kept saying, “mama, mama, look at me!”  When I turned around, she had pulled a yellow cord that had been dangling above her head down and it had become wrapped around the bottom of her neck.  I immediately pulled the yellow cord taught and secured it with a plastic attachment, and told my daughter not to pull on the string, that it could hurt her.

I didn’t think about it again until the CPSC issued a recall on the B.O.B. Revolution strollers last week – because of the strangulation hazard of the drawstring cord. 337,000 single and double B.O.B. strollers have been recalled in the U.S. alone. The recalled strollers were sold at REI, buy buy Baby and other stores nationwide and on the Web at Babiesrus.com, Target.com and Amazon.com between April 2002 and February 2011 for between $300 and $600.

The CPSC is asking consumers to immediately stop using the recalled strollers and remove the drawstring.  If consumers are using a separately purchased Weather Shield or Sun Shield accessory with the recalled stroller, contact B.O.B. Trailers at (855) 242-2245 between 8:30 a.m. and 5 p.m. MT Monday through Friday, or visit the firm’s website atwww.bobcanopy.com for a free canopy retrofit kit.

Recalled B.O.B. Strollers, Courtesy of CPSC

The affected strollers are listed below, by serial number.  You can also visit the CPSC recall notice for more information about this recall.  My family happens to have both the single and double B.O.B. strollers, and both of them have been affected by this recall.

 

Model Serial # ranges
Sport Utility Stroller 12362 – 35107
AA00001 – AA025490
AA900000 – AA999999
Sport Utility Stroller D’Lux 12362 – 35107
AB000001 – AB007940
AB900000 – AB999999
Ironman® 800000 – 803700
AC000001- AC027923
AC900000 – AC999999
Sport Utility Duallie 002001 – 008068
AD000001 – AD011252
AD900000 – AD999999
Ironman® Duallie AE000001 – AE008909
AE900000 – AE999999
Revolution AF000001 – AF189112
AF900000 – AF999999
Revolution 12” AK000001 – AK024149
AK900000 – AK999999
Stroller Strides® AG000001 – AG011163
AG900000 – AG999999
Revolution Duallie AH000001 – AH072921
AH900000 – AH999999
Revolution Duallie 12” AL000001 – AL012657
AL900000 – AL999999
Stroller Strides® Duallie AM000001 – AM003229
AM900000 – AM999999

-Heather

-Do you have a B.O.B. stroller?  Is it the single or double?
-What do you think about this recall?

Other Recent Recalls:

Recall Recap: Britax Chaperone Infant Seat & Children’s Place Ruffle Vests

Check Your Candy – 6 Companies Issue Halloween Candy Recalls

Hyland Teeth Tablets Recalled Due to Concerns Over Belladonna Toxicity

Graco Recalls Strollers After 4 Infants Die From Strangulation

Evenflo Recalls Some Maestro Booster Seats

Jogging Strollers Recalled for Strangulation Hazard

Massive Recall from Fisher-Price: More Than 10 Million Products!!

CPSC Warning: Stop Using Infant Sleep Positioners Immediately

 

Recall Recap: Britax Chaperone Infant Seat & Children’s Place Ruffle Vests

Published on November 4, 2010 in Baby Gear and Recalls. 0 Comments Tags: , , , , , , .

Two recalls were issued in the last week that we wanted to bring to your attention.

Britax Chaperone Infant Seats

Britax has issued a voluntary recall of about 23,000 Chaperone infant car seats manufactured between April 2009 and May 2010 after receiving four reports of harness chest clips breaking. The chest clips were incorrectly produced by the manufacturer resulting in a brittle chest clip which can break and pose a laceration and choking hazard. Model numbers involved in the recall include E9L95P2, E9L95P3, E9L95P5, E9L69N9  (Sold in the US), and E9L69P2, E9L69P3, E9L69P5 (Sold in Canada). The model number and manufacturing date can be found on the underside of the seat.

Consumers will be provided with a free repair kit which includes a replacement clip. Britax will begin contacting registered owners with a notice and replacement clip on or about November 11th according to the NHTSA notice on the recall. If you own an affected seat and have not registered it, you should contact Britax Consumer Services at 888-427-4829, or you can register for the recall at www.chaperoneseatrecall.com.

If your chest clip breaks before you receive a replacement, remove the clip from the harness along with any fragments, and Britax’s safety notice indicates that you can safely use the seat without the clip until the replacement is installed. Just ensure that the harness is positioned over the shoulders and tightened correctly.

Children’s Place Ruffle Vests

Image courtesy CPSC

The Children’s Place has issued a voluntary recall of approximately 3,300 girls’ quilted ruffle vests because metal snaps can detach from the vest posing a choking hazard.

The girls’ ruffle vests are quilted and “chalk” colored with a hood trimmed in fake fur. The vests have a label sewn to the inside side seam of the lining with number #587754 printed on it. The vests were sold online on www.childrensplace.com in September 2010 for about $20.

Consumers who purchased this vest online will be mailed a postage-paid envelope with instructions for returning the vest(s) for a full refund. If you have any questions, you can contact The Children’s Place Services Company LLC at 877-752-2387.

If you enjoy reading PureBebe, please tell your friends and click on “Sign me up!” under “Email Subscription” on the right rail of the screen. By subscribing to our emails, you are telling us that you dig our site and want to read more of our healthy baby news and topics!

Other Recent Recalls:
Hyland Teeth Tablets Recalled Due to Concerns Over Belladonna Toxicity
Graco Recalls Strollers After 4 Infants Die From Strangulation
Evenflo Recalls Some Maestro Booster Seats
Jogging Strollers Recalled for Strangulation Hazard
Massive Recall from Fisher-Price: More Than 10 Million Products!!
CPSC Warning: Stop Using Infant Sleep Positioners Immediately

Check Your Candy – 6 Companies Issue Halloween Candy Recalls 2010

Published on October 27, 2010 in Food and Recalls. 88 Comments Tags: , , , , , , , .

Six Companies (Nestlé®, Hershey, Colombina, Anhing Corp., Cocon Food Industries and Chula Vista Candy Companies) have issued recalls on Halloween candy for a variety of reasons ranging from the discovery of peanuts to high levels of lead found in the candies.

Courtesy of Nestle.com

Nestlé® – RAISINETS® (Made in U.S.A.)
Nestlé® has issued a voluntary recall of its Nestlé® RAISINETS® Fun Size Bags (10oz) with a production code of 02015748/UPC number 2800010255, after three complaints were made from customers finding peanuts. People with allergies or serious sensitivities to peanuts could have a severe allergic reaction if they consume the products. Consumers are being urged to contact Nestlé Consumer Services directly at 1-800-478-5670 for a full refund and discard any remaining packages.

Hershey – York Pieces (Made in U.S.A.)
Hershey has issued a voluntary recall of their 5 oz bag of bite size York Pieces, due to the possibility that small pieces of metal may be found in the product. The affected items have the UPC 34000-11435-000 and production code beginning with the characters 27 or 28. Consumers who have purchased the item in question should contact Hershey Consumer Relations at 1-800-468-1714.

Colombina U.S.A. – Mega Pops Lollipops (Imported from Colombia)
Colombina U.S.A. has issued a voluntary recall of Mega Pops lollipops as they may contain traces of foreign particles and metals. The lollipops come in 14-ounce and 28-ounce cellophane bags containing watermelon, cherry, orange and grape flavored pops. Affected Mega Pops contain UPC Code numbers 0 14272 10873 9 or 0 14272 10862 3, and are in lots marked as Lot #1240695, Lot #1209708, or Lot #1209796. Customers that would like to return the product to the store where they made the purchase may receive a refund or store credit. A 24-hour hotline has also been set up to answer customer questions at 1-888-317-3686.

Anhing Corp. – DaiJyoBu Ginger Candy (Imported from China)
Anhing Corp. has recalled DaiJyoBu Ginger candy, imported from China, after the California Department of Public Health notified the company that the candy contained lead above the state’s legal level. The company says the candy could cause health problems, particularly for infants, small children and pregnant women. The company has asked consumers to not eat the candy and return it to the store of purchase.

Cocon Food Industries – Cocon Grape Gummy Candy (Imported from Malaysia)
The California Department of Public Health (CDPH) warned consumers to discard any Cocon Grape Gummy 100% candy imported from Malaysia after testing revealed high levels of lead (almost twice the legal limit in the state of California) in the candy. California health officials encourage consumers who find Cocon Grape Gummy 100% candy for sale to call the CDPH Complaint Hotline at (800) 495-3232.

Chula Vista Candy Company – Candy El Pecas Saladitos & Candy El Pecas Saladitos con Limon (Imported from China)
CDPH officials are warning customers not to eat “Candy El Pecas Saladitos con Chile” and “Candy El Pecas Saladitos con Limon” after the CDPH found the candy contained seven times the legal limit of lead. Both candies, which are imported from China, are salted plums packaged in 1.5-ounce clear plastic bags. Consumers who find the products for sale are encouraged to call the Department of Health complaint hotline at 1-800-495-3232.

If you enjoy reading PureBebe, please tell your friends and click on “Sign me up!” under “Email Subscription” on the right rail of the screen. By subscribing to our emails, you are telling us that you dig our site and want to read more of our healthy baby news and topics!

Other Recent Recalls:
Hyland Teeth Tablets Recalled Due to Concerns Over Belladonna Toxicity
Graco Recalls Strollers After 4 Infants Die From Strangulation
Evenflo Recalls Some Maestro Booster Seats
Jogging Strollers Recalled for Strangulation Hazard
Massive Recall from Fisher-Price: More Than 10 Million Products!!
CPSC Warning: Stop Using Infant Sleep Positioners Immediately

Hyland Teething Tablets Recalled Due to Concerns over Belladonna Toxicity

Published on October 25, 2010 in Health & Safety, Recalls and Teething. 2 Comments Tags: , , , , , , , , , , .

Over the weekend, Standard Homeopathic Company issued a voluntary recall of all Hyland’s Teething Tablets “in an abundance of caution due to an FDA investigation of its manufacturing facility”. The company’s press release indicates that

Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage…

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols.

A little vague, don’t you think? The FDA’s press release which followed provides more information, highlighting two major concerns:

(1) Testing of the company’s product showed inconsistent levels of belladonna, which can be toxic in large doses. The FDA has received reports of serious adverse events in children taking the product that are consistent with belladonna toxicity.

(2) The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have childproof caps.

While the company’s recall lists specific UPC#’s included in the recall, there’s no need to check the UPC because all Hyland’s teething tablets are subject to the recall. The FDA has recommended that consumers stop using the product immediately and dispose of any in your possession. I nearly bought this product last week for my teething infant because I’d heard the benefits touted by some of my other mom friends who’ve used it, but ultimately I decided against it until I had an opportunity to do some more research on the ingredients. I’m glad I waited.

Belladonna, otherwise known as Deadly Nightshade, is a poisonous plant which can be fatal in large doses and, according to this article published in the Encyclopedia of Alternative Medicine, can be toxic even in small doses and should always be taken under the direction of a doctor. Belladonna alkaloids, the active ingredient of the plant which make it toxic, are the very same ingredient used in homeopathic remedies to treat various illnesses and symptoms including seizures, fever, acute pain, restlessness, and inflammation among others.

According to the Hyland Teething Tablet Fact Sheet, belladonna is included in the tablets to ease inflammation and discomfort of the child’s gums. It is manufactured from the whole plant, of which a small portion is Belladonna alkaloids. The Fact Sheet goes on to assure consumers of its safety and miniscule dosage level; however, the article I previously referred to states that “some patients experience toxicity at unusually low doses”. The alkaloids work by blocking certain nerve impulses in the parasympathetic nervous system which regulates certain involuntary bodily functions. Symptoms of belladonna toxicity or overdose include extreme restlessness, seizures, fast heart rate, increased body temperature, dry skin and dry mouth, skin flushing, constipation, decreased urination, disorientation, hallucinations, and dilated pupils. According to the FDA’s FAQ on the recall, drowsiness may also be seen in infants. The FDA urges anyone who experiences these symptoms to contact their doctor and report the side effects to the FDA through the MedWatch program, by phone at 1-800-332-1088, or online at http://www.fda.gov/medwatch/index.html.

Each article I read about belladonna regards it as something not to be messed with. The FDA itself indicated that its use needs to be “carefully controlled” which is why the Standard Homeopathic Company’s substandard manufacturing control process is of such concern. Honestly, even once the Company gets its act together, I don’t think I’d be comfortable giving this or any other product containing belladonna to my child unless prescribed by a doctor.

Another safety concern that should be noted, last month a medical alert was issued warning of infant botulism cases linked to consumption of homeopathic teething products containing chamomile (Hyland’s was not named, but the product does contain chamomile). Apparently, dried chamomile can contain trace amounts of botulism which are perfectly tolerable for adults and older children but may be concentrated enough to harm young infants. Rumor has it Hyland’s is currently under investigation for this as well.

-Jasmine

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