Blacksmith Brands, Inc., issued a recall of four of its PediaCare cold and allergy products for children on the heels of the poor conditions found in the McNeil Consumer Healthcare Fort Washington, Pa., plant, the U.S. Food and Drug Administration announced. The four product lines were made at the plant under a contract with McNeil, a division of Johnson & Johnson.
McNeil is now the subject of a criminal investigation following a spate of product recalls involving some of the best known over-the-counter medicines: Tylenol, Motrin and Benadryl. Childrens' medicines have been particularly hard-hit in these recalls.
Every lot of the following PediaCare products are subject to this recall:
PediaCare Multi-Symptom Cold (4 ounces)
PediaCare Long Acting Cough (4 ounces)
PediaCare Decongestant (4 ounces)
PediaCare Allergy and Cold (4 ounces)
Conditions at the McNeil plant, which has been temporarily shut down since that company's recalls were announced, led to this recall, Blacksmith said. While PediaCare products have not been the subject of complaints, consumers have reported finding particles in McNeil products made at the plant and concentration of ingredients was reportedly incorrect in some batches, which would prevent correct dosing.
"As a precautionary step, we have initiated our own recall to address any possible concerns that parents may have," Blacksmith CEO Peter Mann said in a statement published on the company's website.
Consumers are urged to get rid of any of the recalled products. If you have any of the recall products, Blacksmith is offering consumers a coupon for a free replacement product when they return to store shelves, but you will need information from the labels to qualify -- so call before disposing off the bottles. Contact Blacksmith during normal business hours at (888) 474-3099 or read the company's FAQ on the recall.
Blacksmith said it has arranged for the products to be made elsewhere and expects to have them back on store shelves in July.
The following products are not being recalled: PediaCare Allergy, PediaCare Gentle Vapors Plug-in Units, and PediaCare Gentle Vapors refills.