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Pain Medicine Recalled


January 21, 2021

Particulate matter discovered in multiple lots of oxycodone hydrochloride oral solution has prompted Genus Lifesciences Inc. to voluntarily recall more than two dozen lots of the pain medication. The recall was announced in the January 20, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects oxycodone hydrochloride oral solution, 5 mg/5 mL unit dose cups (unit dose cup NDC 64950-354-05; 40-cup case NDC 64950-354-45; 50-cup case NDC 64950-354-55) from the following lots, which were distributed throughout the United States:

  • 35400119A, 35400219A, 35400319A, 35400419A, 35400519A, and 35400619A (Exp. 12/31/20);
  • 35400719A and 35400819A (Exp. 1/31/21);
  • 35400919A, 35401019A, and 35401119A (Exp. 2/28/21);
  • 35401219A and 35401319A (Exp. 4/30/21);
  • 35401419A, 35401519A, and 35401619A (Exp. 5/31/21);
  • 35401719A and 35401819A (Exp. 7/31/21);
  • 35401919A and 35402019A (Exp. 8/31/21);
  • 35402119A, 35402219A, 35402319A, and 35402419A (Exp. 9/30/21);
  • 35402519A (Exp. 10/31/21);
  • 35402619A and 35402719A (Exp. 11/30/21);
  • 35400120A, 35400220A, 35400320A, and 35400420B (Exp. 12/31/21); and
  • 35400520A and 35400620A (Exp. 1/31/22).

Genus Lifesciences Inc. initiated the recall December 23, 2020. On January 15, 2021, the FDA designated it Class III. Under the recall classification, use of the affected medication is not likely to cause harm.

Available with a prescription, oxycodone is a narcotic medication used to treat moderate to severe pain.

Jolynn Tumolo

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