# FDA recall D-747-2014

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-11-14.

## Product

Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA.  NDC: 0093-5414-95.

## Reason for recall

Failed Stability Specifications: this product is below specification for preservative content.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-747-2014
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-14
- **Report date:** 2014-01-29
- **Termination date:** 2014-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sellersville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-747-2014

## Citation

> AI Analytics. FDA recall D-747-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-747-2014. Source: US FDA. Licensed CC0.

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