October 12, 2018
Teva Pharmaceuticals USA has issued a voluntary recall for 313 bottles of clozapine orally disintegrating tablets, 12.5 mg, 100-count (NDC 0093-5416-01). According to the October 10, 2018, US Food and Drug Administration (FDA) Enforcement Report, samples tested out-of-specification for disintegration.
The recall affects 313 bottles from lot 34034024B (Exp. 2/20). The tablets were distributed throughout the United States.
Teva Pharmaceuticals voluntarily initiated the recall September 21, 2018. The FDA issued a Class II designation October 1, 2018. The classification communicates that use of the product could cause temporary or medically reversible harm, or a remote possibility of serious harm.
Clozapine is a prescription antipsychotic medication used to treat patients with schizophrenia.
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