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More Children’s Medicine Made at J&J Facility Is Recalled


Four children’s cough and cold medicines made at a Johnson & Johnson plant shuttered because of manufacturing problems were recalled Friday, a month after different kids’ medicines made at the facility were withdrawn.

Blacksmith Brands, which sells the PediaCare cough and cold medicines made at the plant in Fort Washington, Pa., said on its website that it was issuing the recall for precautionary reasons. It said it hasn’t received any complaints or reports of side effects connected to the PediaCare products.

The new recall, which a Blacksmith Brands spokesman said affects at most 100,000 bottles, comes a day after Johnson & Johnson was grilled at a congressional hearing over manufacturing lapses at the plant and how its McNeil Consumer Healthcare unit has handled recalls of over-the-counter medicines.

The latest recall affects PediaCare’s Multi-Symptom Cold, Long Acting Cough, Decongestant, and Allergy and Cold medicines. Blacksmith Brands said it has told retailers to take the four products from store shelves and advised parents to stop using the bottles.

The four PediaCare medicines had been owned by J&J, which sold them to Blacksmith Brands in November along with several other over-the-counter consumer products. That was after regulators found several violations of good-manufacturing practices at the Fort Washington plant. The private-equity firm Charlesbank Capital Partners formed Blacksmith, of Tarrytown, N.Y., shortly before the purchase of the products. Blacksmith had long planned for two other manufacturing plants to take over production of its PediaCare products starting in July, a spokesman said.

In an interview Friday before the Blacksmith Brands announcement, Rep. Edolphus Towns (D., N.Y.), chairman of the House Oversight and Government Reform Committee, vowed to step up a probe of the J&J unit’s history of handling defective drugs, indicating the company faces protracted public scrutiny of its manufacturing problems.

Rep. Towns said he wanted to investigate McNeil’s role in a contractor’s apparent effort in late 2008 to buy up defective Motrin pills off retail shelves. Regulators discovered the contractor’s work, and the company issued a recall in July 2009.

A McNeil spokeswoman said the company also planned to look into the contractor’s work and report back to the committee.

The Oversight Committee hearing was called as a result of the McNeil unit’s recall on April 30 of certain Benadryl, Motrin, Tylenol and Zyrtec medicines for infants and children. The Food and Drug Administration says that recall, though not posing much of a safety risk, indicated systemic compliance problems inside J&J’s McNeil unit.

Mr. Towns said the committee would continue investigating the problems and also wants to examine whether the FDA needs more staff and the power to order a recall. Now, companies must volunteer to conduct a recall. The committee also wants to make sure the recent recall was aggressive enough, Rep. Towns added, expressing concern that some parents might not have gotten the message after the company announced the action late on a Friday.

“We cannot take this lightly, and I want J&J to know we are not,” Rep. Towns said.

The unnamed contractor’s work involving defective Motrin emerged during the hearing when lawmakers cited FDA documents and a memo from the contractor to its workers.

The McNeil unit hired the contractor after discovering in late 2008 that some Motrin wasn’t dissolving correctly, according to the materials. The company told the FDA it had hired the contractor for statistical sampling, the FDA documents said.

Colleen Goggins, world-wide chairwoman of J&J’s consumer group, told lawmakers the New Brunswick, N.J., company kept the FDA fully informed of its actions and didn’t have “any intent to mislead or hide anything.” She said she didn’t know what the McNeil unit told the contractor to do.

(Source: Wall Street Journal)



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