FDA recall D-0070-2021
AVKARE Inc. · Class II · 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
Reason for recall
Failed Dissolution Specifications
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2020-10-30
- Report date
- 2020-11-18
- Termination date
- 2023-06-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pulaski, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2021