D-205-2013 Class II Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
March 27, 2013
Initiation Date
February 13, 2013
Termination Date
January 31, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
136,720 cartons

Product Description

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 Pattern

Nationwide

Code Information

Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A