# FDA recall D-1127-2017

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2017-05-02.

## Product

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

## Reason for recall

CGMP Deviations

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1127-2017
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-02
- **Report date:** 2017-09-13
- **Termination date:** 2018-03-28

- **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-1127-2017

## Citation

> AI Analytics. FDA recall D-1127-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1127-2017. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
