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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

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.
Recall Number D-1436-2012
Classification Class III
Code Info Lot #s: 412572A, 412572B, Exp 11/12
Product Distributed Qty 18,938 cartons
Reason For Recall Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.

Event Detail

Event Id 62407
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories Inc
City Corona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.