FDA recall D-205-2013

Watson Laboratories Inc · Class II · drug

Product

ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28

Reason for recall

Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-02-13
Report date: 2013-03-27
Termination date: 2014-01-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-205-2013