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Substandard manufacturing prompts FDA recall of PediaCare products
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Blacksmith Brands, after conferring with the FDA, initiated a voluntary recall of four PediaCare children’s cough and cold products manufactured at the same McNeil Consumer Healthcare plant that was recently shut down because of poor quality manufacturing.
“We’re taking this voluntary step because protecting consumers and maintaining their trust are essential to our company’s core values,” Peter Mann, chairman and CEO of Blacksmith Brands, said in a press release. “Our brands have a heritage that has made them the favorites of millions of families, and we are the guardians of that heritage.”
McNeil Consumer Healthcare recalled a number of liquid products intended for use in infants and children — including Tylenol, Motrin, Zyrtec and Benadryl — in May after finding that its Fort Washington, Pa., facility did not meet the FDA’s current good manufacturing practice requirements.
Products included in the recall are:
- PediaCare Multi-Symptom Cold 4 oz; UPC# 3 0045-0556-05 9;
- PediaCare Long Acting Cough 4 oz; UPC# 3 0045-0465-04 7;
- PediaCare Decongestant 4 oz; UPC# 3 0045-0554-04 8;
- PediaCare Allergy and Cold 4 oz; UPC# 3 0045-0552-04 4.
As of press time, FDA had not received any reports of adverse events or complaints regarding the PediaCare medications but still recommended that consumers immediately discontinue use and discard any remaining product. Blacksmith Brands has also requested that retail and wholesale customers pull the products from their shelves and warehouses and return them to the company.
Arrangements will be made to produce the items at new manufacturing plants, and Blacksmith Brands expects to resume shipments of PediaCare products this month. – by Melissa Foster
Recalls of manufactured pharmaceutical products as described in this report represent an important aspect of the pharmaceutical manufacturing and regulatory process. While this recall was voluntarily initiated by the manufacturer, input by the FDA was likely an important consideration. Careful analysis of pharmaceutical manufacturing techniques is necessary to maintain public and health professional confidence in medication products. The public and health professionals should also assume some degree of responsibility for maintaining high medication safety standards, by reporting suspected or known problems with medication products, including significant adverse effects, to the FDA or the manufacturer.
– Edward A. Bell, PharmD, BCPS
Professor
of Clinical Sciences, Drake University College of Pharmacy,
Des Moines, IA