Multi-event January 2024 FDA Recall Nortrel by Teva Pharmaceuticals Usa, Inc
This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on January 25, 2024 for the product Nortrel. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0321-2024
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
01-25-2024
02-21-2024
12,916 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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
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.
nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Batch or Lot Expiration Information
Lot# : 100042978, Exp 7/31/2024
Affected Packages Involved in this Recall
Recall Number: D-0322-2024
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
01-25-2024
02-21-2024
19,824 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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
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.
nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Batch or Lot Expiration Information
Lot# : 100040731, Exp 7/31/2024
