FDA-Drug2024-02-21Class III

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58

Teva Pharmaceuticals USA, Inc
Hazard

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Sold states
nationwide
Affected count
19,824 cartons
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0322-2024

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