D-0428-2024 Class II Terminated
FDA drug recall D-0428-2024 was initiated by Teva Pharmaceuticals USA, Inc on Mar 7, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Mar 6, 2025). Affected quantity: 92,676 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 3, 2024
- Initiation Date
- Mar 7, 2024
- Termination Date
- Mar 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92,676 cartons
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
USA nationwide.
Code Information
Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0428-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026