Recalls / Class III
Class IIID-497-2013
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
- Brand name
- Camrese
- Generic name
- Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol
- NDC
- 0093-3134
- FDA application
- NDA021840
- Affected lot / code info
- NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.
Why it was recalled
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 120,049 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-14
- FDA classified
- 2013-05-30
- Posted by FDA
- 2013-06-05
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-497-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.