December 10, 2020
Six lots of aripiprazole tablets are being recalled because samples failed to meet dissolution specifications during routine testing, according to the December 9, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following aripiprazole products:
- 15-mg aripiprazole tablets in 30-count bottles (NDC 60429-449-30) from lots GS026353, GS027150, GS027653, and GS028044 (Exp. 2/21). The tablets were manufactured by Apotex Inc., packaged by Golden State Medical Supply Inc., and distributed throughout the United States.
- 15-mg aripiprazole tablets in cartons of 30 single-tablet blister packs (NDC 0904-6512-04) from lots T02520 and T02637 (Exp. 2/21). The tablets were manufactured by Apotex Inc. and distributed throughout the United States by Major Pharmaceuticals.
Golden State Medical Supply Inc. and the Harvard Drug Group voluntarily initiated the recalls November 17, 2020, and November 18, 2020, respectively. By December 1, 2020, the FDA had designated both recalls Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Aripiprazole is a prescription antipsychotic used to treat bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder.