Blacksmith Brands, Inc., Tarrytown, NY 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.
Consumers with questions may contact Blacksmith Brands on Friday, May 28th 5pm – 9pm EST; Saturday-Monday 9am-5pm EST; and normal business hours thereafter at (888) 474-3099. More information is available at blacksmithbrands.com1.
Any adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http:www.fda.gov/safety/medwatch/default.htm
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.
