Camrese(TM) recall: Impurity Out of Spec
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC…
Why was Camrese(TM) recalled?
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC…
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Quantity
- 120,049 blister packs
- Distribution
- Nationwide
- Recall date
- June 5, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)