Recalls / Class II
Class IID-0428-2024
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
- Brand name
- Tri-lo-sprintec
- Generic name
- Norgestimate And Ethinyl Estradiol
- NDC
- 0093-2140
- FDA application
- ANDA076784
- Affected lot / code info
- Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 92,676 cartons
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-03-07
- FDA classified
- 2024-03-28
- Posted by FDA
- 2024-04-03
- Terminated
- 2025-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0428-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.