Recalls / Class III
Class IIID-094-2013
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.
- Affected lot / code info
- 432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13
Why it was recalled
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, Corona, California 92880-2882
Distribution
- Quantity
- 63,627 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-13
- FDA classified
- 2012-12-18
- Posted by FDA
- 2012-12-26
- Terminated
- 2013-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-094-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.