Recall Headache: Drug Plants get Oversight

Wednesday, March 16, 2011 @ 09:03 PM gHale


After a series of serious recalls, three Johnson & Johnson manufacturing plants will fall under the supervision of U.S. health authorities.

J&J’s McNeil unit has recalled more than 300 million bottles and packages of Tylenol, Motrin, Rolaids, Benadryl and other products in the past year over faulty manufacturing.

The U.S. Food and Drug Administration said the action, called a consent decree, prevents McNeil from making consumer medicines at a large plant in Fort Washington, PA, until the agency certifies the company corrected its quality lapses.

It also sets a strict timetable to rectify manufacturing problems at McNeil’s plants still operating in Lancaster, PA and Las Piedras, Puerto Rico.

J&J said two company executives, Veronica Cruz, vice president of quality at J&J’s McNeil Consumer Healthcare unit, and Hakan Erdemir, vice president of operations at McNeil, are defendants in the consent decree.

“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” said Deborah Autor, head of compliance in the FDA’s drug division.

Some of the lapses led to metal particles entering liquid medicines, and also included mislabeling and moldy odors.

While the medicines recalled were not harmful to any consumers, they did tarnish J&J’s reputation, which the company built on a pledge to serve its patients first and deserve their trust.

In February, the company recalled Sudafed allergy tablets for incorrectly repeating the word “not” on its label to say “do not not divide, crush, chew or dissolve the tablet.”



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