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The FDA, in conjunction with pharmaceutical company Blacksmith Brands, Inc., announced a voluntary recall of all of the company's PediaCare products. 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. It was conditions at this plant that were the basis for the recall of the Johnson & Johnson children's Tylenol products at the end of April. A recent FDA inspection at that facility found serious problems in meeting the FDA's current good manufacturing practice requirements.
According to the May 28 press release by the FDA, the recall was not initiated as a result of any consumer reports of sickness or other problems and as yet, no consumer complaints have been received about the safety or purity of the products. As with some of the recalled Tylenol products, tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.
The four PediaCare items under recall are as follows:
"We're taking this voluntary step because protecting consumers and maintaining their trust are essential to our company's core values," said Blacksmith Brands Chairman and CEO Peter Mann. "Our brands have a heritage that has made them the favorites of millions of families and we are the guardians of that heritage."
The FDA states that while the potential for serious medical problems is remote, the company advises consumers who have purchased these recalled products to discontinue use.
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 http://blacksmithbrands.com/.
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.
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