Status
Terminated
Drug Enforcement D-1436-2012
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Classification
Class III
Report Date
August 8, 2012
Termination Date
March 18, 2013
Product Information
- 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.
- Product quantity
- 18,938 cartons
- Reason for recall
- Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Watson Laboratories Inc
- Address
-
311 Bonnie Cir, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1436-2012
- Event ID
- 62407
- Recall initiation date
- June 5, 2012
- Center classification date
- August 1, 2012
- Code info
- Lot #s: 412572A, 412572B, Exp 11/12
- More code info
- —