FDA Drug recall D-1397-2012
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3…
- FDA Drug
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3… by Teva Pharmaceuticals Usa, citing impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1397-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-02 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
Reason
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Identifiers
| code_info | Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, 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-1397-2012%22
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