Drug & medication recalls Moderate risk

The Harvard Drug Group recalls Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Onta…

Recall date
November 18, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0114-2021
FDA classification
Class II
Brand / firm
The Harvard Drug Group
Sold / distributed
Nationwide

Why it was recalled

Failed Dissolution Specifications: Out of specification for dissolution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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