Camrese — Class III drug recall D-497-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-06-05, distributed nationwide. Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detec
| Recall number | D-497-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-03-14 |
| Classified | 2013-05-30 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 120,049 blister |
| Reason classes | chemical contamination, specification failure |
| NDC | 00093-3134-82, 00093-3134-91, 00555-3134-82 |
| Lot numbers | 33802566A, 33802967A, 33803529A, 33803609A |
| Expiration dates | 2013-03, 2013-08, 2013-10, 2013-11 |
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 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
Reason for recall
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-497-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.