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Schizophrenia Med Recalled


May 31, 2018

Mylan is voluntarily recalling numerous lots of loxapine capsules due to unspecified deviations from Current Good Manufacturing Practice regulations, according to the May 30, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects:

  • 25-mg loxapine capsules, USP, 100-count bottles (NDC 0378-7025-01) from Mylan Pharmaceuticals from lots 3083756 (Exp. 3/31/19), 3083757 (Exp. 3/31/19), 3083758 (Exp. 3/31/19), 3083759 (Exp. 3/31/19), 3083760 (Exp. 3/31/19), and 3083761 (Exp. 3/31/19);
  • 50-mg loxapine capsules, USP, 100-count bottles (NDC 0378-7050-01) from Mylan Pharmaceuticals from lots 3079386 (Exp. 10/31/18), 3079387 (Exp. 10/31/18), 3079388 (Exp. 10/31/18), 3083762 (Exp. 3/31/19), 3083763 (Exp. 3/31/19), 3083764 (Exp. 3/31/19), 3083765 (Exp. 3/31/19), 3083766 (Exp. 3/31/19), and 3083767 (Exp. 3/31/19);
  • 25-mg loxapine capsules, USP, packaged in blister cards of 100 capsules each (NDC 51079-902-20), manufactured by Mylan Pharmaceuticals and recalled by Mylan Institutional (doing business as UDL Laboratories) from lot 3090454 (Exp. 3/19); and
  • 50-mg loxapine capsules, USP, packaged in blister cards of 100 capsules each (NDC 51079-903-20), manufactured by Mylan Pharmaceuticals and recalled by Mylan Institutional (doing business as UDL Laboratories) from lot 3092310 (Exp. 3/19).

The recalled capsules were distributed throughout the United States, including Puerto Rico.

Mylan initiated the recall April 24, 2018. The FDA designated it Class II May 22, 2018. Under Class II recalls, use of the affected drug could cause temporary or medically reversible adverse health consequences, with a remote probability of serious harm.

Loxapine is a prescription antipsychotic medication used to treat patients with schizophrenia or schizoaffective disorder.

Jolynn Tumolo


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