# FDA recall D-1109-2015

> **Blenheim Pharmacal, Inc.** · Class II · drug recall initiated 2015-05-22.

## Product

Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By:  Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02

## Reason for recall

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

## Distribution

Indiana

## Key facts

- **Recall number:** D-1109-2015
- **Recalling firm:** Blenheim Pharmacal, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-22
- **Report date:** 2015-06-03
- **Termination date:** 2016-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Blenheim, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1109-2015

## Citation

> AI Analytics. FDA recall D-1109-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1109-2015. Source: US FDA. Licensed CC0.

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