Recalls / Class III
Class IIID-1384-2012
Product
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, 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 #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
Why it was recalled
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
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
- 40,750 Dispensers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-23
- FDA classified
- 2012-06-19
- Posted by FDA
- 2012-06-27
- Terminated
- 2013-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1384-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.