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Antipsychotic Drug Recalled


May 19, 2017

Sun Pharmaceutical Industries, Inc. is recalling 30-count, 100-count, and 1000-count bottles of olanzapine tablets, 20 mg, 10 mg, 7.5 mg, and 2.5 mg, because of impurities, according to the May 17, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The voluntary recall was initiated March 22, 2017, and designated Class III by the FDA May 10, 2017. A Class III designation advises use of the drug is not likely to cause adverse health consequences.

The affected bottles were distributed across the United States and in Puerto Rico. The recall includes:

  • 14,784 bottles of olanzapine tablets, 20 mg, 30-count bottle lot JKR5759A (Exp. 4/18); 100-count bottle lots JKP0943A (Exp. 4/17) and JKR5520A (Exp. 4/18); and 1000-count bottle lot JKP0988A (Exp. 4/17).
  • 38,316 bottles of olanzapine tablets, 10 mg, 30-count bottle lots KP1354A (Exp. 3/17), JKP2746A (Exp. 6/17), and JKR5751A (Exp. 4/18); 100-count bottle lots JKP1355A (Exp. 3/17), JKP2738A and JKP3145A (Exp. 6/17), and JKR5476A (Exp. 4/18); and 1000-count bottle lots JKP1353A (Exp. 3/17), and JKP3146A and JKP2746B (Exp. 6/17).
  • 6138 bottles of olanzapine tablets, 7.5 mg, 30-count bottle lots JKP3150B (Exp. 6/17) and JKR5749A (Exp. 6/18); 100-count bottle lots JKP2757A (Exp. 5/17), JKP3149A and JKP3150A (Exp. 6/17), and JKR5049A (Exp. 4/18); and 1000-count bottle lot JKP2758B (Exp. 5/17).
  • 60 bottles of olanzapine tablets, 2.5 mg, 1000-count bottle lots JKP2751A (Exp. 5/17) and JKR5048A (Exp. 4/18).

Olanzapine is an atypical antipsychotic used in the treatment of schizophrenia, bipolar disorder, and depression.

Jolynn Tumolo

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