Reported Apr 17, 2013 · Terminated
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet…
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, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only
- Manufactured ByBarr Laboratories, Inc., Pomona, NY 10970
- Manufactured ForTeva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66
- Lot codes and dates
Lot #: 33803603A33803604AExp 11/1333803996Aand 33803997AExp 03/14
- Amount recalled
- 71,893 dispensers
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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