Four cold and cough medicines for children have been recalled that were sold under the PediaCare brand by Blacksmith Brands Inc. of Tarrytown, N.Y., the U.S. Food and Drug Administration announced.
The company said it was voluntarily recalling all lots of the medications because they had been made in the Fort Washington, Pa., manufacturing plant by McNeil Consumer Healthcare that was shut down after a recent FDA inspection found serious problems meeting the federal agency's good manufacturing practice requirements.
The four recalled PediaCare products were:
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
Blacksmith and the Food and Drug Administration said that the recall was not due to any reports of problems with the PediaCare products, but because tiny particles have been found in non-PediaCare products made at the Fort Washington plant.
The company advised those who have the recalled products to discontinue use and noted that it had arranged to produce the products at other plants and resume shipments in July.
"We're taking this voluntary step because protecting consumers and maintaining their trust are essential to our company's core values," said Peter Mann, chief executive officer and chairman of Blacksmith. "Our brands have a heritage that has made them the favorites of millions of families and we are the guardians of that heritage."