Why it was recalled
Failed Dissolution Specifications
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
Lot numbers, UPCs & expiration codes
Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0428-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 7, 2024
- FDA report date
- Apr 3, 2024
- Quantity
- 92,676 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0428-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94183
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
- Postal code
- 07054-1120
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0428-2024
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 92,676 cartons
- Termination date
- Mar 6, 2025
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 7, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2024