Multi-event January 2022 FDA Recall Mimvey by Teva Pharmaceuticals Usa
This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on January 7, 2022 for the product Mimvey. The FDA reported the reason for recall as mislabeling. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0522-2022
Mislabeling
01-07-2022
02-09-2022
6430 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
06-01-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
Batch or Lot Expiration Information
Lot# : 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023
Affected Packages Involved in this Recall
Recall Number: D-0521-2022
Mislabeling
01-07-2022
02-09-2022
218174 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
06-01-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
Batch or Lot Expiration Information
Lot# : 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
