Pediacare Recall: Children’s Medication Made at Problematic McNeil Plant

A recall for Pediacare has been issued as part of an expansion of the McNeil Consumer Healthcare children’s medication recall issued last month, as the drugs were manufactured at the same plant that federal regulators shut down due to repeated problems and violations.

The PediaCare recall was announced on May 28 by FDA and Blacksmith Brands, Inc. the manufacturer of PediaCare products. The company indicates that the recall was issued as a precautionary step, because the medications were made at McNeil’s Fort Washington, Pennsylvania, factory. There have been no adverse events reported in connection to the recalled PediaCare products.

The recall of PediaCare includes all lots of the drugs made at the McNeil plant, including:

• PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
• PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
• PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
• PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

The recall does not affect any other PediaCare products, which were produced elsewhere. Blacksmith Brands recommends that consumers discontinue use of the recalled PediaCare products, and has requested that wholesalers and retailers who have the products in stock return them to the company.

The initial McNeil children’s medication recall affected 40 different liquid medication products, including Tylenol, Benadryl, Motrin and Zyrtec. McNeil is a subsidiary of Johnson & Johnson.

Several quality control problems were uncovered at the company’s Ft. Washington plant, leading the FDA to issue warning letters, shut down the plant, and suspend all of the McNeil’s children medication production.

Following reports of particulate matter found floating in liquid children’s drugs, FDA inspectors found raw ingredients contaminated with bacteria, as well as “super potent” doses of Tylenol and other problems at the factory. While the FDA and Johnson & Johnson officials say that the risk of injury, illness or death from the problems were remote, the FDA has received nearly 800 complaints about problems with the medications, including at least seven reports of deaths.

FDA officials say that so far none of the complaints or the deaths have shown a link between the recalled medications and adverse medical events, but some are still under investigation.

Consumers with questions about the PediaCare recall can find more details at blacksmithbrands.com. Anyone whose children suffer an adverse event linked to the recalled products should contact FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/safety/medwatch/default.htm.