# FDA recall D-0828-2020

> **Ascend Laboratories LLC** · Class II · drug recall initiated 2020-01-24.

## Product

Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.

## Reason for recall

cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0828-2020
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-24
- **Report date:** 2020-02-12
- **Termination date:** 2021-10-29

- **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-0828-2020

## Citation

> AI Analytics. FDA recall D-0828-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0828-2020. Source: US FDA. Licensed CC0.

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