Blacksmith Brands, USDA recalls four PediaCare children's products

Blacksmith Brands, Inc., in consultation with the U.S. Food and Drug Administration, 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.

Consumers who have purchased these recalled products should discontinue use of these products. Blacksmith Brands is asking customers to return the product to Blacksmith Brands.

Consumers with questions may contact Blacksmith Brands today-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.

To provide these valued products to consumers again as quickly as possible, Blacksmith Brands has arranged to make them at new manufacturing plants and expects to resume shipments of the recalled items in July from those new facilities.

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.

Blacksmith Brands markets, sells and distributes over-the-counter drug and personal care products that for years have provided consumers with superior, dependable results.