# FDA recall D-0827-2020

> **Ascend Laboratories LLC** · Class III · drug recall initiated 2020-01-22.

## Product

Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054,  NDC 67877-438-30.

## Reason for recall

Failed Dissolution Specifications: low out of specification results for dissolution testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0827-2020
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-22
- **Report date:** 2020-02-12
- **Termination date:** 2021-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2020

## Citation

> AI Analytics. FDA recall D-0827-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0827-2020. Source: US FDA. Licensed CC0.

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