Nationwide Voluntary Recall Of Four PediaCare Children's Products
On May 28, 2010, the U.S. Food and Drug Administration (FDA) issued the following recall information regarding four over-the-counter children’s medications marketed under the PediaCare line.
The recall was prompted after an FDA inspection of the facility where these products are made was shut down for alleged violations of the FDA good manufacturing practices requirements.
Blacksmith Brands, Inc., in consultation with the U.S. Food and Drug Administration, is voluntarily recalling all lots of four children's products in the PediaCare line. These products are sold exclusively in the United States. These products were manufactured for Blacksmith Brands by McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc., (a Johnson & Johnson Company) at McNeil's Fort Washington, PA plant.
The four PediaCare items involved in the recall are:
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
Blacksmith Brands initiated the recall as a precautionary step because the products were made at the McNeil Consumer Healthcare Fort Washington, PA plant that has been temporarily shut down. A recent FDA inspection at that facility found serious problems in meeting the FDA's current good manufacturing practice requirements. The recall was not initiated as a result of any consumer reports of adverse events and no consumer complaints have been received about the safety or purity of the products.
While the recall was not initiated as a result of either any consumer reports of adverse events or complaints with respect to the PediaCare products, tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.
While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use. Blacksmith Brands is asking Retail and Wholesale customers to withdraw the four products from their shelves and warehouses and return the product to Blacksmith Brands.
Items not involved in this recall are PediaCare Allergy 4oz., PediaCare Gentle Vapors Plug in Units, and PediaCare Gentle Vapors refills, all of which are produced in other facilities.
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