FDA recall D-689-2013

Teva Pharmaceuticals USA, Inc. · Class III · drug

Product

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-03-15
Report date: 2013-07-17
Termination date: 2014-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-689-2013