Recalls / Class II
Class IID-0070-2021
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
- Affected lot / code info
- Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 15,678 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-10-30
- FDA classified
- 2020-11-06
- Posted by FDA
- 2020-11-18
- Terminated
- 2023-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.