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J&J's troubled McNeil unit recalls more products

200,000 bottles of infant Motrin recalled after plastic particles found in API
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Manufacturing issues continue to plague Johnson & Johnson's ($JNJ) McNeil Consumer Healthcare unit, this time related to problems with the active pharmaceutical ingredient in some Motrin for infants. The company is recalling three lots, or about 200,000 bottles, of its concentrated Motrin infants' drops after plastic particles were detected in the API.

According to the FDA MedWatch alert, the company discovered tiny plastic particles in an unreleased lot of the Motrin during manufacturing. In its own statement, McNeil said the particles were approximately 1 mm in size, or about the size of a poppy seed. The company said it tracked the problem to a supplier of ibuprofen, the API in the over-the-counter treatment. The company voluntarily recalled the three lots already released to the market that had been made with the same batch of active ingredient. It claims it is unlikely there would be any adverse medical events related to the plastic, but decided it was best to recall the products anyway. The company also said it is has worked with its supplier on a solution to the problem and that it is already in place.

The company said the recall affects its Concentrated Motrin Infants' Drops Original Berry Flavor 1/2 fl oz. but not its Concentrated Infants' Motrin Drops Dye-Free Berry Flavor 1 fl oz. bottles. It also said that children's or adult Motrin products also were unaffected by the issues.

Johnson & Johnson has spent years trying to get its OTC manufacturing in order. It closed its Fort Washington, PA, OTC plant 2010 after it recalled tens of millions of consumer products, including Tylenol and Motrin products. McNeil in 2011 signed the FDA consent decree and has since spent more than $100 million to upgrade the key OTC facility. But its problems have not been isolated to the U.S. plant. In May it ran into serious problems in South Korea. A criminal investigation was launched there after J&J's Janssen unit released some Children's Tylenol products that contained excessive levels of acetaminophen. Authorities were reportedly upset that the plant waited a month to report the mistake.

J&J is not the only company struggling with quality issues in OTC products. Novartis ($NVS), which also has been battling quality issues in its own OTC unit, late last month recalled 4.4 million bottles of its popular Maalox products due to manufacturing problems. According to an FDA Enforcement report, the bottles may be missing a lot number or expiration date, or those identifiers may be illegible on the outer plastic bottle packaging.

- here's the FDA alert
- see the McNeil statement

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J&J consumer operations face problems in Asia but close to resolving them in U.S. 
CEO of J&J OTC unit in Korea faces criminal action over plant foul-up
Novartis can't get past foul-ups at consumer plant; recalls 4.4 million bottles of Maalox