# FDA recall D-0163-2017

> **Ascend Laboratories LLC** · Class II · drug recall initiated 2016-11-02.

## Product

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only  Manufactured by: Alkem Laboratories Ltd., Mumbai  - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ  NDC 67877-217-10

## Reason for recall

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

## Distribution

AL, FL, GA, SC & TN

## Key facts

- **Recall number:** D-0163-2017
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-02
- **Report date:** 2016-12-07
- **Termination date:** 2017-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2017

## Citation

> AI Analytics. FDA recall D-0163-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0163-2017. Source: US FDA. Licensed CC0.

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