D-1436-2012 Class III Terminated
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