Recalls / Class III
Class IIID-683-2013
Product
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
- Brand name
- Jolessa
- Generic name
- Levonorgestrel / Ethinyl Estradiol
- NDC
- 0555-9123
- FDA application
- NDA021544
- Affected lot / code info
- NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was 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
- 54,412 blister packs
- Distribution pattern
- Nationwide distribution. No foreign or government accounts.
Timeline
- Recall initiated
- 2013-03-15
- FDA classified
- 2013-07-05
- Posted by FDA
- 2013-07-17
- Terminated
- 2014-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-683-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.