RECALL

Antiseizure Tablets Recalled

January 26, 2018

Unichem Pharmaceuticals (USA) Inc. is voluntarily recalling 100-count bottles of divalproex sodium delayed-release tablets USP, 500 mg (NDC 29300-140-01), after metronidazole powder was found in 1 of the bottles, according to the January 24, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall spans 96,876 bottles from lot ZDPH17040. Bottles from the lot were distributed across the United States.

Unichem Pharmaceuticals initiated the recall December 19, 2017. On January 17, 2018, the FDA designated the recall class II, indicating use of the affected tablets could cause temporary or reversible adverse effects with a remote probability of serious harm.

Divalproex sodium is a prescription medication used to treat seizure disorders as well as manic episodes in patients with bipolar disorder. It is also used to prevent migraine headaches.

Metronidazole is an antibiotic used to treat bacterial infections.

Jolynn Tumolo


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