March 2024 FDA Recall Tri-lo-sprintec by Teva Pharmaceuticals Usa, Inc
D-0428-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on March 7, 2024 for the product Tri-lo-sprintec. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0428-2024
Failed Dissolution Specifications
03-07-2024
04-03-2024
92,676 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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, 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.
USA nationwide.
03-06-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
Batch or Lot Expiration Information
Lot# 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
