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J&J recalls moldy Risperdal Consta, tainted infant Motrin liquid

Johnson & Johnson recently voluntarily recalled two drugs manufactured by third parties, and the recalls are prompting important questions about the company’s quality control procedures. The two defective drugs were:

  • Risperdal Consta -- an injectable, long-acting version of the antipsychotic pill-form drug Risperdal -- which was recalled after batches were found to contain mold. Risperdal Consta is manufactured by Ireland-based Alkermes plc, which referred questions by the New York Times back to Johnson & Johnson.
  • 200,000 bottles of liquid Motrin for infants, which were recalled because batches were found to contain bits of plastic about the size of poppy seeds, which could easily be ingested by babies. The liquid ibuprofen was produced by J&J’s over-the counter division McNeil Consumer Healthcare and manufactured by a third party, but neither McNeil nor Johnson & Johnson would name the manufacturer.

In both cases, Johnson & Johnson said that it had not received reports of serious harm and that it considered the risk to patients to be low.

However, since 2011 J&J’s division McNeil has been under order by the Food and Drug Administration and the Justice Department to overhaul three manufacturing plants. The FDA found numerous violations of the federal Food, Drug, and Cosmetic Act at two plants in Pennsylvania and one in Puerto Rico.

That scrutiny hasn’t solved the problem apparently, as in recent years, however, J&J has had to recall a surprisingly large number of its products, including defective drugs and medical devices, many of which are sold internationally. For example, in May the company recalled Children’s Tylenol sold in South Korea after it was discovered it contained too much acetaminophen, its active ingredient. Overdosing on acetaminophen can cause acute liver failure. In June, J&J had to recall birth control pills from markets in Latin America, Europe and Asia because the hormones weren’t releasing properly.

“Even the most careful company is occasionally going to have a recall,” said a University of Michigan professor who follows the industry, but the September recalls seem to indicate continued problems at Johnson & Johnson. “They have not repaired the damage that was done to Johnson and Johnson’s quality control infrastructure.”

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