FDAClass IIApril 3, 2024

Tri-Lo-Sprintec recall: Failed Dissolution

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

Why was Tri-Lo-Sprintec recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Teva Pharmaceuticals USA, Inc
Quantity
92,676 cartons
Distribution
USA nationwide.
Recall date
April 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls