CLASS II Drug recall · Reported 22 Feb 2017 · FDA Enforcement Report
Mimvey Lo (estradiol and norethindrone acetate tablets USP) recalled
Teva Pharmaceuticals USA is recalling Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg per blister, distributed nationwide in the US. The recall was initiated on 2 Feb 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0479-2017
- FDA event ID
- 76383
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Feb 2017
- FDA classified
- 16 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 2 Feb 2017 | Recall initiated by company | |
| 16 Feb 2017 | Classified by FDA | +14 days |
| 22 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Which lots are affected?
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
Where was it sold?
Nationwide in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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