← FDA ENFORCEMENT
D-0428-2024Class II

Teva Pharmaceuticals USA, Inc

Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Terminated
Report date
2024-04-03
Distribution
USA nationwide.
Firm state
NJ
Product quantity
92,676 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

Product description

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

Code / lot info

Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.