D-1436-2012 Class III Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
August 8, 2012
Initiation Date
June 5, 2012
Termination Date
March 18, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,938 cartons

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.

Reason for Recall

Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.

Distribution Pattern

Nationwide.

Code Information

Lot #s: 412572A, 412572B, Exp 11/12