PediaCare Products Made by Johnson & Johnson Unit RecalledJun 1, 2010 | Parker Waichman LLP
Four popular PediaCare medications were recalled over the weekend. The medications were made for Blacksmith Brands, Inc. at a manufacturing facility owned by Johnson & Johnson’s McNeil Consumer Healthcare Unit.
The plant, located in Fort Washington, PA, was shut down in April after McNeil recalled more than 40 varieties of children’s medications made there. Tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.
There have been no consumer reports of adverse events or complaints with respect to the PediaCare products. Blacksmith Brands said it was initiating the PediaCare recall as a precautionary measure. The four products subject to this recall include:
• 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
About 100,000 bottles of PediaCare products are involved in this recall.
While the potential for serious medical events is remote, Blacksmith Brands is advising consumers who have purchased these recalled products to discontinue use. Blacksmith Brands is asking retail and wholesale customers to withdraw the four products from their shelves and warehouses and return the product to the company.
On April 30, McNeil recalled more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid. At the time, the company said some drugs might contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
According to a Reuters report, the recall was the largest involving children’s medicines in the history of the U.S. Food & Drug Administration (FDA), and involved 70 percent of the market for over-the-counter pediatric liquid medicines.
A memo prepared by Congressional staffers that was released lasts week revealed that between January 2008 and April 2010, the FDA received 775 reports of adverse events – including 30 deaths – involving the recalled drugs. After the recall, the agency received several hundred more complaints, including seven deaths, the memo said. The FDA is still investigating some of the adverse event reports to determine if the events were related to a child taking one of the recalled medicines.
An FDA inspection of McNeil’s Fort Washington facility cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The problems prompted the FDA to widen its investigation of McNeil’s manufacturing practices, and it is now inspecting the company’s other facilities in Lancaster, PA and Puerto Rico.
Last week, at a Congressional hearing looking into the recalls, officials from the FDA said the agency was considering other enforcement action against McNeil and Johnson & Johnson, including possible criminal charges.