Drug Enforcement D-0428-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

March 6, 2025

Product Information

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
Product quantity
92,676 cartons
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0428-2024
Event ID
94183
Recall initiation date
March 7, 2024
Center classification date
March 28, 2024
Code info
Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
More code info
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