06/01/2010 // West Palm Beach, FL, USA // Tara Monks // Tara Monks
Tarrytown, NY – On Friday, May 28, 2010, Blacksmith Brands, Inc., in cooperation with the U.S. Food and Drug Administration, announced a voluntary recall of four lines of children’s products under the PediaCare label. The products were manufactured for Blacksmith Brands by McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc., which is a Johnson & Johnson Company.
The products were manufactured at McNeil’s Ford Washington, Pennsylvania plant and sold exclusively within the United States.
According to the press release, the four lines of products 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 issued the recall as a precautionary step. The McNeil Consumer Healthcare plant was temporarily shut down after a recent FDA inspection found serious problems with the facility’s ability to meet the good manufacturing practice requirements held by the FDA.
The recall was not issued due to consumer complaints or reports of adverse reactions to the product. It was reported that tiny particles were found at non-PediaCare products that were manufactured at the McNeil facility.
The FDA and Blacksmith explain, “while the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.”
Blacksmith Brands has asked retail and wholesale customers to withdraw the products from their shelves and return them to the organization.
Consumers with questions are prompted to contact Blacksmith Brands at (888) 474-3099 during normal business hours. Information is also available at www.blacksmithbrands.com.
Any adverse events that could be related to the use of the PediaCare products should be reported to the FDA’s Med Watch Program. Consumers can fax the complaints to (800) FDA-0178 or send them via mail to Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. The Med Watch website also accepts mail: http://www.fda.gov/safety/medwatch/default.htm.
Blacksmith Brands Chairman and CEO Peter Mann stated, “We’re taking this voluntary step because protecting consumers and maintaining their trust are essential to our company’s core values.”
Blacksmith Brands has arranged to make the recalled products at different manufacturing plants and expects to resume shipments of the products in July.
Items that were not involved in the recall are PediaCare Allergy 4oz, PediaCare Gentle Vapors Plug in Units and PediaCare Gentle Vapors refills. These products were manufactured in different facilities.
Phone: (866) 598-1315