Lawmakers Investigating PediaCare RecallJun 3, 2010 | Parker Waichman LLP
A Congressional committee is seeking information regarding last week’s recall of PediaCare medicines made at a facility operated by Johnson & Johnson’s McNeil Consumer Healthcare unit. The House Committee on Oversight and Government Reform was already investigating manufacturing practices at McNeil, which recalled dozens of children’s medicines made at the same Fort Washington, PA facility in April.
The PediaCare recall was issued by Blacksmith Brands, which had acquired the popular line of over-the-counter cold medicines from Johnson & Johnson last year, though they were still made at the Pennsylvania facility. Blacksmith said at the time that there had been no consumer reports of adverse events or complaints with respect to the recalled PediaCare products, and that the recall was a precaution.
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
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.
The Fort Washington, PA facility was temporarily shut down after the April recall. The Food & Drug Administration (FDA) cited more than 20 manufacturing problems at the plant, 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.
According to The Wall Street Journal, the House Committee on Oversight and Government Reform has written Blacksmith Brands seeking information about the PediaCare recall. The committee is seeking all records tied to the recall and communications with J&J, McNeil and the FDA.
“We cannot take any recalls at this plant lightly,” committee Chairman Edolphus Towns, D-N.Y., said in a statement.
According to the Journal, Blacksmith Brands has characterized the committee’s inquiry as ’standard” and says it intends to cooperate.