The manufacturer of PediaCare has recalled four brands of the popular over-the-counter children’s medication after federal inspectors found poor quality standards at the Johnson & Johnson plant where the medicine was manufactured.
Blacksmith Brands announced the recall of about 100,000 units of PediaCare sold nationwide under the brands PediaCare Multi-Symptom Cold, PediaCare Long Acting Cough, PediaCare Decongestant and PediaCare Allergy and Cold.
All of the medications were manufactured by McNeil Consumer Healthcare at its Fort Washington, Penn., plant. McNeil is owned by Johnson & Johnson.
Blacksmith Brands initiated the voluntary recall as a precautionary step after a recent FDA inspection found more than 20 “serious problems” at the plant. The manufacturing facility is currently shut down.
Blacksmith Brands stressed the recall was not initiated as the result of any reported “adverse events” and that no consumer complaints had been received about the safety or purity of any of the PediaCare products.
“We’re taking this voluntary step because protecting consumers and maintaining their trust are essential to our company’s core values,” Blacksmith Brands Chairman and CEO Peter Mann said. “Our brands have a heritage that has made them the favorites of millions of families and we are the guardians of that heritage.”
The four PediaCare items involved in the recall are:
- 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 Brands is asking retail and wholesale customers to withdraw the four products from their shelves and warehouses and return them to the company.
The company has arranged to make the PediaCare products at new manufacturing plants and expects to resume shipments in July from those new facilities.
Last month, Johnson & Johnson’s McNeil division recalled more than 40 varieties of children’s medicines also manufactured at the now-shuttered plant. That recall involved children and baby formulations of Tylenol, Motrin, Zyrtec and Benadryl.
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.
