Recalls / Class III
Class IIID-1436-2012
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
- Lot #s: 412572A, 412572B, Exp 11/12
Why it was recalled
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, N/A, Corona, California 92880-2882
Distribution
- Quantity
- 18,938 cartons
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-06-05
- FDA classified
- 2012-08-01
- Posted by FDA
- 2012-08-08
- Terminated
- 2013-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1436-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.