Drug product
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.
D-1436-2012
Product summary
- Event
- Event 62407
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,938 cartons
- Official record key
drug-enforcement:D-1436-2012
Official wording
Reason: Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Code information: Lot #s: 412572A, 412572B, Exp 11/12
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out-of-specification