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 Pharmaceutical

FDA recall notice · announced June 27, 2012 · Teva Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

Notes

Distribution: Nationwide
Lot/code information: Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
Quantity: 40,750 Dispensers
Status: Terminated
Products in this recall event:
- 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., (D-1384-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.