The Harvard Drug Group recalls Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontar
Recalled December 9, 2020 · FDA recall D-0114-2021 · The Harvard Drug Group
Hazard
Failed Dissolution Specifications: Out of specification for dissolution. · FDA Class II
Units
841 cartons
Sold at
Nationwide
Description
Failed Dissolution Specifications: Out of specification for dissolution.
Product
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
Manufacturer(s)
The Harvard Drug Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →