Drug Enforcement D-205-2013

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

Status

Terminated

Classification

Class II

Report Date

March 27, 2013

Termination Date

January 31, 2014

Product Information

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
Product quantity
136,720 cartons
Reason for recall
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
311 Bonnie Cir, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-205-2013
Event ID
64358
Recall initiation date
February 13, 2013
Center classification date
March 19, 2013
Code info
Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
More code info
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