Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carto...
FDA Recall #D-0321-2024 — Class III — January 25, 2024
Product Description
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Reason for Recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recalling Firm
Teva Pharmaceuticals USA, Inc — Parsippany, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
12,916 cartons
Distribution
nationwide
Code Information
Lot #: 100042978, Exp 7/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated