Aripiprazole Tablets recall: Failed Dissolution
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
Why was Aripiprazole Tablets recalled?
Failed Dissolution Specifications: Out of specification for dissolution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
- Product
- 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
- Recalling firm
- Apotex Corp.
- Quantity
- a)552 bottles; b) 3192 bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- November 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)