Johnson & Johnson recalls 43 children's drugs

03 May 2010

1

Johnson & Johnson's McNeil division has recalled 43 child and infant liquid formulations, including Tylenol, Motrin, Zyrtec and Benadryl, after the company and the US Food and Drugs Administration (US FDA) announced on Friday that some of these might contain overly high levels of active and inactive ingredients or tiny metallic particles.

While no injuries or deaths have been reported, and the chances of injury from the recalled products were remote, consumers, the company has warned consumers not to use the recalled products.

The voluntary recall comes in the wake of a 19 April FDA inspection of a McNeil plant in Fort Washington, Pennsylvania, that revealed "manufacturing deficiencies," according a Washington Post report.

"Some of the products included in the recall may 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," a company news release stated.
The company has urged parents to report any unusual symptoms to a health care professional in children who might have taken the recalled products.

Parents have also been cautioned against giving children adult formulation of the medications. The company said alternative brands of the products, including generic medications, were available and parents who had questions about alternative treatments should consult their child's pediatrician.

Recalled products may be returned for refund or exchanged for a fresh product on resolution of manufacturing issues.

Though McNeil did not say how many units were under recall, analysts say the number would likely be huge.

The recalled products were in distribution in the US, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

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