Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0...
FDA Recall #D-094-2013 — Class III — December 13, 2012
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: Out-of-specification results were obtained for a known impurities.
Recalling Firm
Watson Laboratories Inc — Corona, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
63,627 cartons
Distribution
Nationwide
Code Information
432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated