FDA recall D-681-2013

Teva Pharmaceuticals USA, Inc. · Class III · drug

Product

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Distribution

Nationwide distribution. No foreign or government accounts.

Key facts

Status: Terminated
Initiation date: 2013-03-15
Report date: 2013-07-17
Termination date: 2014-04-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-681-2013