Mimvey Lo — Class II drug recall D-0479-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-02-22, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity
| Recall number | D-0479-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-02-02 |
| Classified | 2017-02-16 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 17,473 cartons |
| Reason classes | specification failure |
| NDC | 00093-5454-18, 00093-5454-62 |
| Lot numbers | 05/17, 08/17, 33809881A, 33811151A |
Product
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
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-0479-2017. 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.