Recall: Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg

Product Details

Product Description: Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36

Recall Number D-854-2013

Classification Class III

Code Info Lots: LF01643C, LF01644C, Exp 7/14

Product Distributed Qty 8, 681 unit cartons

Reason For Recall Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card

Event Detail

Event Id 65877

Product Type Drugs

Status Ongoing

Recalling Firm

Sandoz Incorporated

City Broomfield
State CO
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-08-07

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide