December 07, 2018
A metal shard found in a tablet has prompted Ascend Laboratories to voluntarily recall one lot of quetiapine tablets USP, according to the December 5, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 400-mg quetiapine tablets in 100-count bottles (NDC 67877-248-01) from lot 7143908 (Exp. 11/20). The bottles were distributed throughout the United States.
Ascend Laboratories initiated the recall November 14, 2018. On November 28, 2018, the FDA designated it Class II, signaling use of the affected drug could cause temporary or medically reversible adverse health consequences. Although remote, a possibility of serious harm also exists.
Quetiapine is a prescription antipsychotic medication used to treat patients with schizophrenia, bipolar disorder, and depression.
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