# FDA recall D-1407-2014

> **Caraco Pharmaceutical Laboratories, Ltd.** · Class II · drug recall initiated 2014-04-09.

## Product

Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40

## Reason for recall

Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.

## Distribution

OH

## Key facts

- **Recall number:** D-1407-2014
- **Recalling firm:** Caraco Pharmaceutical Laboratories, Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-09
- **Report date:** 2014-07-02
- **Termination date:** 2014-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Detroit, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1407-2014

## Citation

> AI Analytics. FDA recall D-1407-2014. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1407-2014. Source: US FDA. Licensed CC0.

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