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February 20, 2002

Schering-Plough Has Recalled

Kenilworth, NJ (SafetyAlerts) - Schering-Plough Corp. is recalling batches of its best-selling allergy drug Claritin from stores and wholesalers because a decongestant ingredient does not dissolve fast enough, but says patients with the drug do not need to return it.

The company issued a voluntary recall Tuesday of certain lots of Claritin-D 12-hour extended release tablets manufactured between August 1999 and June 2001 because some tablets did not release enough pseudoephedrine within five hours.

The company said adequate levels of pseudoephedrine were released about 25 minutes later than called for under its specifications. It said the delay does not hurt the drug's effectiveness, and said there is no medical risk in taking it.

Company spokesman Robert Consalvo said federal regulations require drug manufacturers to meet certain specifications in order to sell a particular drug. Because of the problem Schering-Plough found with the Claritin lots, it had to recall the product from stores.

Consumers who received prescriptions from pharmacies would not know which lots their pills came from, he said. Because of this, and the company's belief that the drugs are still safe and effective, the recall was not extended to the patient level, he said.

Consalvo said it believes most of the affected lots have already been sold or used by patients. He said the recall involved 97 lots, but would not say how many pills that constituted, saying that figure is proprietary information.

Affected lots carry a prefix number of "0" or "1" (representing the years 2000 and 2001). Five additional lots, numbered 9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042, which were manufactured in 1999, are also included in the recall.

The company has begun manufacturing and shipping new batches of Claritin to retailers.

Claritin is the company's top-selling product, bringing in $3.1 billion in 2001. But the drug's basic patent expires at the end of this year, and competitors are already seeking permission to sell over-the-counter versions.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.