FDA-Drug2024-04-03Class II

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

Teva Pharmaceuticals USA, Inc
Hazard

Failed Dissolution Specifications

Sold states
USA nationwide.
Affected count
92,676 cartons
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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

Official notice

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

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