FDA Drug recall D-684-2013
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, N…
- FDA Drug
- Class III
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class III recall of Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, N… by Teva Pharmaceuticals Usa, citing failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-684-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
Reason
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Identifiers
| ndc | 0555-9034-79 |
|---|---|
| ndc | 0555-9034-58 |
| code_info | NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-684-2013%22
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