FDA recall D-684-2013

Teva Pharmaceuticals USA, Inc. · Class III · drug

Product

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

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-684-2013