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-094-2013
Product summary
- Event
- Event 63906
- Status
- Terminated
- Classification
- Class III
- Quantity
- 63,627 cartons
- Official record key
drug-enforcement:D-094-2013
Official wording
Reason: Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Code information: 432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out-of-specification