Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2024-02-21
Distribution
nationwide
Firm state
NJ
Product quantity
19,824 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Product description
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
Code / lot info
Lot #: 100040731, Exp 7/31/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.