# FDA recall D-346-2014

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2013-02-22.

## Product

Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.

## Reason for recall

Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-346-2014
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-22
- **Report date:** 2013-12-18
- **Termination date:** 2013-12-30

- **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-346-2014

## Citation

> AI Analytics. FDA recall D-346-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-346-2014. Source: US FDA. Licensed CC0.

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