Drug Enforcement D-094-2013

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

Status

Terminated

Classification

Class III

Report Date

December 26, 2012

Termination Date

December 4, 2013

Product Information

Product description
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Product quantity
63,627 cartons
Reason for recall
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
311 Bonnie Cir

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

Codes & Dates

Recall number
D-094-2013
Event ID
63906
Recall initiation date
December 13, 2012
Center classification date
December 18, 2012
Code info
432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13
More code info
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