FDA recall D-854-2013

Sandoz Incorporated · Class III · drug

Product

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

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-08-07
Report date: 2013-08-14
Termination date: 2014-07-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-854-2013