FDA recall D-497-2013

Product

Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-14

Report date

2013-06-05

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-497-2013