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More over-the-counter infants and children’s drugs are being recalled – this time four PediaCare-brand products – as a precautionary measure because the medicines were manufactured in the same plant that was deemed unsafe and temporarily closed last month by the Food and Drug Administration (FDA).
Blacksmith Brands announced the voluntary recall this week of all lots of PediaCare Multi-Symptom Cold 4-ounce, PediaCare Long Acting Cough 4-ounce, PediCare Decongestant 4-ounce, and PediaCare Allergy and Cold 4-ounce. The products were made at McNeil Consumer Healthcare-PPC, Inc., a Johnson & Johnson Company, at McNeil’s Fort Washington, Penn., plant. The products are sold exclusively in the United States.
More than 1,500 lots of children’s medicine such as Tylenol, Motrin and Benadryl were recalled May 1, 2010 after an FDA investigation found serious lapses in quality and security at the manufacturing plant. The FDA’s inspection report listed some 20 violations, including 46 consumer complaints over the past year of foreign materials and black or dark specks floating in the medicines. Johnson & Johnson was cited for not following up on the consumer complaints. The company faces possible criminal penalties as the House Committee on Oversight and Government Reform investigates the issue.
No consumer complaints were made on the PediaCare products to date. While the risk of adverse events is remote, as a precaution consumers who have PediaCare products in their possession are advised to discontinue using them. Questions may be directed to Blacksmith Brands at (888) 474-3099. Any adverse events with these or any other products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.
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