Drug product
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
D-0070-2021
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 86695
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,678 bottles
- Official record key
drug-enforcement:D-0070-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications