Reported Jun 5, 2013 · Terminated
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2…
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?
- Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
- Lot codes and dates
- NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.
- Amount recalled
- 120,049 blister packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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