Recalls / Class III
Class IIID-246-2013
Product
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
- Brand name
- Jolessa
- Generic name
- Levonorgestrel / Ethinyl Estradiol
- NDC
- 0555-9123
- FDA application
- NDA021544
- Affected lot / code info
- Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
Why it was recalled
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 71,893 dispensers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-12
- FDA classified
- 2013-04-10
- Posted by FDA
- 2013-04-17
- Terminated
- 2014-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-246-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.