# FDA recall D-0070-2021

> **AVKARE Inc.** · Class II · drug recall initiated 2020-10-30.

## 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

- **Recall number:** D-0070-2021
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2021

## Citation

> AI Analytics. FDA recall D-0070-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0070-2021. Source: US FDA. Licensed CC0.

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