PediaCare Products Recalled Due to Risk for Contamination

Tarrytown, NYBlacksmith Brands, Inc, is 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:

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