# FDA recall D-497-2013

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-03-14.

## Product

Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA

## Reason for recall

Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-497-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-14
- **Report date:** 2013-06-05
- **Termination date:** 2014-01-15

- **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-497-2013

## Citation

> AI Analytics. FDA recall D-497-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-497-2013. Source: US FDA. Licensed CC0.

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