D-205-2013 Class II Terminated
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