Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling. The recall affects 6,430 cartons distributed throughout the USA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for mislabeling only, with no reported adverse events or safety hazard explicitly stated in the source. Class III recalls are typically scored 1 or 2, and a labeling-only issue without reported harm falls at the low end of the scale.
Plain-English summary
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg in cartons of 28 tablets due to mislabeling. The affected product is NDC 0093-5455-42, manufactured by Barr Laboratories, Inc., in Pomona, NY and distributed nationwide throughout the USA.
The recall affects three specific lots: Lot# 100018610 (expiration 03/2022), Lot# 100021521 (expiration 09/2022), and Lot# 100024575 (expiration 01/2023). A total of 6,430 cartons were distributed.
This is a voluntary recall initiated by Teva Pharmaceuticals USA on January 7, 2022, and classified by the FDA as Class III. Patients currently taking Mimvey should consult their healthcare provider about their medication. The recall was terminated on June 1, 2023.
The recalled product
- Product
- MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
- Brand
- MIMVEY
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: 100018610
- Exp 03/2022
- 100021521
- Exp 09/2022
- 100024575
- Exp 01/2023
Distribution
Distributed nationwide across the United States.
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- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
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