FDA-Drug2020-12-09Class II
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
The Harvard Drug Group
Hazard
Failed Dissolution Specifications: Out of specification for dissolution.
Sold states
Nationwide
Affected count
841 cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, N/A, Livonia, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0114-2021Don't want to check this manually?
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