FDAFDA · Food and drugs·Recall number D-1285-2022
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
Published July 27, 2022 · Recall initiated: July 7, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Corp.
- Distributor
- USA Nationwide
- Lot
- Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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