The Children’s Tylenol, Motrin, Zyrtec and Benadryl recall has expanded to include four PediaCare medications. Blacksmith Brands, the manufacturer of PediaCare children’s medications, and the FDA has issued a voluntary recall of children’s PediaCare liquid cold, cough and allergy medications. The recall was initiated as a precaution because the medications were manufactured at the same McNeil Consumer Healthcare plant in Fort Washington, Pennsylvania that produced recalled Children’s Tylenol, Motrin, Zyrtec and Benadryl. The plant has been closed since late April. The PediaCare recall affects approximately 100,000 packages of medication.
ALL LOTS of four types of children’s PediaCare medications are affected by the recall.
PediaCare Multi-Symptom Cold 4oz.
PediaCare Long Acting Cough 4oz.
PediaCare Decongestant 4oz.
PediaCare Allergy and Cold 4oz.
The recall does not include any other PediaCare products. PediaCare Allergy 4oz., PediaCare Gentle Vapors Plug-In Units, and PediaCare Gentle vapors refills are not affected by the recall. They are produced at other facilities.
Blacksmith brands CEO Peter Mann said in a statement, “we’re taking this voluntary step because protecting consumers and maintaining their trust are essential to our company’s core values. Our brands have a heritage that has made them the favorites of millions of families and we are the guardians of that heritage.”
The PediaCare medications were formerly owned by Johnson & Johnson. They were sold to Blacksmith Brands in November 2009. At the time of the Children’s Tylenol, Motrin, Zyrtec and Benadryl recall, the recalled PediaCare medications were still being manufactured at the McNeil facility responsible for bacterial contamination, super concentrated formulations, and metallic particles in Children’s Tylenol, Motrin, Zyrtec and Benadryl. Production of the recalled PediaCare medications were set to begin being manufactured at two Blacksmith Brands plants in July. Blacksmith Brands will continue with that plan. New lots of the recalled PediaCare medications will begin being produced at the new facilities in July.
If you have any of the recalled PediaCare children’s medications, do not use them. If you are giving them to your children, stop using them immediately. The FDA is instructing parents and caregivers to use generic equivalents of all Children’s Tylenol, Motrin, Zyrtec and Benadryl medications as well as the recalled PediaCare medications listed above. There have been no specific problems associated with the recalled PediaCare medications.
One troubling aspect of the PediaCare recall is why it took so long to connect the medications to the McNeil plant where they were produced. Many are asking why the PediaCare medications were not recalled along with the other Children’s Tylenol, Motrin, Zyrtec and Benadryl medications in May. Perhaps the Congressional hearing played a role in the recall of PediaCare.
Consumers wishing to contact Blacksmith Brands with questions may do so by calling (888) 474-3099. For more information, go to the Blacksmith Brands website. Consumers who believe they have suffered any adverse effects from the recalled PediaCare medications should report to the FDA’s Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the Med Watch website.
To request a coupon for a free replacement of a recalled PediaCare product once it becomes available again, consumers will need to call Blacksmith Brands at (888)474-3099. Consumers will need the NDC number and Lot number from the PediaCare bottle. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.
For information on the beginning of the Children’s Tylenol, Motrin, Zyrtec and Benadryl recall see Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded.
Sources
Blacksmith Brands
FDA
PediaCare
CNM News Network
