FDA recall D-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

Reason for recall

Failed Dissolution Specifications

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2024-03-07

Report date

2024-04-03

Termination date

2025-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0428-2024