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
Reported: December 9, 2020 Initiated: November 18, 2020 #D-0114-2021
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 841 cartons
- Distribution
- Nationwide
- Location
- Livonia, MI
Frequently Asked Questions
What product 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. Recalled by The Harvard Drug Group. Units affected: 841 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Moderate. Recall number: D-0114-2021.
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