# FDA recall D-1186-2014

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2014-01-27.

## Product

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.

## Reason for recall

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1186-2014
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-27
- **Report date:** 2014-04-09
- **Termination date:** 2015-05-12

- **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-1186-2014

## Citation

> AI Analytics. FDA recall D-1186-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1186-2014. Source: US FDA. Licensed CC0.

---

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