Drug product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-0990-2019
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 82296
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 2947 and b) 3379
- Official record key
drug-enforcement:D-0990-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications