Errin — Class III drug recall D-689-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-07-17, distributed nationwide. Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was de
| Recall number | D-689-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 154,536 cartons |
| Reason classes | chemical contamination, specification failure |
| NDC | 00555-0344-58 |
| Lot numbers | 12/14, 3/15, 33801773A, 33801774A, 33801775A, 33801776A, 33802427A, 33802428A, 33802429A, 33802430A, 33802925A, 33802926A, 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, 6/15, 7/14, 8/14, 9/14 |
Product
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was 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-689-2013. 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.