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10/3/2003

Counterfeit Zyprexa Recalled

Kate Traynor

St. Louis-based D&K Health Resources Inc., a regional drug wholesaler, has initiated a recall of Zyprexa, Eli Lilly and Company's olanzapine antipsychotic drug, because of counterfeiting concerns.

According to an enforcement report from the Food and Drug Administration (FDA), some bottles labeled to contain 5 mg, 10 mg, 15 mg, or 20 mg tablets of Zyprexa in 60-count bottles have been relabeled or repackaged and instead contain "different strengths or mixed strength tablets...or bear extended expiration dates."

The recall affects approximately 32,000 60-count bottles with the following lot numbers:

  • 6AA66A (5-mg tablets)
  • 6AH19A, 7AA39A, and 7EA97A (10-mg tablets)
  • 6AH35A, 6AG70A, 7AA77A, 7ED06A, 7ED00A, and 7EA53A (15-mg tablets)
  • 7AA79A, 7EC85A, 7EA19A, and 7EA22A (20-mg tablets)

According to the Oct. 1 FDA enforcement report, D&K announced the recall by e-mail on Aug. 25.

Molly Salky, vice president of investor relations for D&K, confirmed the accuracy of FDA's information but declined to provide a copy of the e-mail notification, which the company regards as confidential correspondence.

Salky said pharmacies that obtained the affected lots should "contact whoever supplied them with the product" for instructions about its return. She said that the material should be returned to D&K only if it was purchased from the company.

Salky added that D&K did not obtain the suspect Zyprexa directly from Lilly and is working with the manufacturer to "untangle the web" related to the product recall.

"Normally, the recalling firm is more typically the manufacturer," she said. "We are simply the go-between."