# FDA recall D-578-2013

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-03-19.

## Product

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

## Reason for recall

CGMP Deviation; cotton coil is missing in some packaged bottles

## Distribution

Nationwide

## Key facts

- **Recall number:** D-578-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-19
- **Report date:** 2013-06-12
- **Termination date:** 2013-12-24

- **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-578-2013

## Citation

> AI Analytics. FDA recall D-578-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-578-2013. Source: US FDA. Licensed CC0.

---

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