Schering-Plough recalls Claritin-D lots

WASHINGTON (Reuters Health) – Schering-Plough Corp. said on Tuesday that it is recalling certain lots of its seasonal allergy drug Claritin-D 12 Hour (loratadine/pseudoephedrine) because some tablets in the lots did not fully release the pseudoephedrine component during routine testing.

The firm said it believes the products are clinically safe and effective, but that during a routine quality check, some of the tablets did not release a full dose of the decongestant pseudoephedrine at the fifth hour. However, 25 minutes later, the tested samples did meet specifications.

The Claritin-D extended release tablets are indicated for 12-hour relief of seasonal allergies.

The company said it believes the recalled products are safe and effective for patients, and that there is no need for consumers to return previously-purchased medications. Instead, the recall is directed to wholesale accounts and retail pharmacies.

The recalled products include any lot with a prefix number of 0 or 1, as well as lots bearing the numbers 9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042. The products were manufactured between August 1999 and June 2001.

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