The U.S. Food and Drug Administration (FDA) announced that Blacksmith Brands, Inc., of Tarrytown, NY, is voluntarily recalling all lots of four children’s medicines because of their manufacture at the dirty Fort Washington, PA plant of McNeil Consumer Healthcare, a division of McNeil-PPC, Inc. and part of the Johnson & Johnson Family of Companies.
The following PediaCare over-the-counter (OTC) products affected by the recall:
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
According to a Wall Street Journal article, the recall involves about 100,000 bottles of the medications.
There have been no adverse events or consumer complaints reported, however Blacksmith Brands initiated the recall as a precautionary step because the FDA found serious violations causing the closure of the McNeil manufacturing facility.
“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."
Consumers with questions may contact Blacksmith Brands at (888) 474-3099. More information is available at blacksmithbrands.com.
Prompted by a routine FDA inspection, McNeil Consumer Healthcare voluntary recalled 43 children’s and infant’s over-the-counter medications distributed to thirteen countries due to quality issues in April 2010. A report released by the FDA showed more than 20 manufacturing problems at the Fort Washington, PA plant and found raw ingredients contaminated by bacteria. Johnson & Johnson is currently appearing before a congressional hearing regarding the problems.
In March 2010, McNeil recalled certain lots of Children’s Tylenol and Children’s Zyrtec after finding that some product bottles purchased from an external supplier did not meet specifications because plastic areas of the bottle were “thin-walled,” possibly effecting stability of the product over time due to increased exposure to light.
In January 2010, McNeil recalled an extensive list of 49 Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Josephs products due to an unusual moldy, musty or mildew-like odor caused by the degrading of a chemical treating the wood pallets used to transport and store product packaging materials. It caused incidences of nausea, stomach pain, vomiting and diarrhea.
In September 2009, McNeil recalled Children’s and Infants’ Tylenol® liquid products, stating that the recall was due to an inactive ingredient that did not meet all quality standards. A letter to healthcare professionals detailed the recall was actually attributed to a bacteria, Burkholderia cepacia (B. cepacia), detected in bulk raw material.