Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reported: November 25, 2020 Initiated: November 11, 2020 #D-0106-2021
Product Description
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- a)552 bottles; b) 3192 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326. Recalled by Apotex Corp.. Units affected: a)552 bottles; b) 3192 bottles.
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 November 25, 2020. Severity: Moderate. Recall number: D-0106-2021.
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