Reported Jun 27, 2012 · Terminated
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day…
Teva Pharmaceuticals USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512
Is this the product you have?
- 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 byBarr Laboratories, Inc., Pomona, NY 10970
- Manufactured forTeva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66
- Lot codes and dates
Lot #'s 33801826AExp 1/201333802144A33802323AExp 3/201333802519AExp 6/2013
- Amount recalled
- 40,750 Dispensers
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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