FDAFDA · Food and drugs·Recall number D-0106-2021
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
Published November 25, 2020 · Recall initiated: November 11, 2020
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: Out of specification for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Corp.
- Distributor
- Distributed Nationwide in the USA
- Lot
- a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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