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
Reported: June 5, 2013 Initiated: March 14, 2013 #D-497-2013
Product Description
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
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 120,049 blister packs
- Distribution
- Nationwide
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 120,049 blister packs.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2013. Severity: Low. Recall number: D-497-2013.
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