PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 3, 2024 Initiated: March 7, 2024 #D-0428-2024

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

Details

Units Affected
92,676 cartons
Distribution
USA nationwide.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 92,676 cartons.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on April 3, 2024. Severity: Moderate. Recall number: D-0428-2024.