Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reported: July 27, 2022 Initiated: July 7, 2022 #D-1285-2022
Product Description
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason for Recall
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 2010 bottles
- Distribution
- USA Nationwide
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326. Recalled by Apotex Corp.. Units affected: 2010 bottles.
Why was this product recalled? ▼
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1285-2022.
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