# FDA recall D-0533-2023

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2023-03-14.

## Product

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

## Reason for recall

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0533-2023
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-14
- **Report date:** 2023-04-05

- **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-0533-2023

## Citation

> AI Analytics. FDA recall D-0533-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0533-2023. Source: US FDA. Licensed CC0.

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