# FDA recall D-409-2014

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2013-09-17.

## Product

Quinapril Tablets USP, 10 mg, 90 count bottle,  Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09

## Reason for recall

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-409-2014
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-17
- **Report date:** 2014-01-22
- **Termination date:** 2016-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-409-2014

## Citation

> AI Analytics. FDA recall D-409-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-409-2014. Source: US FDA. Licensed CC0.

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