Why it was recalled
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 412572A, 412572B, Exp 11/12
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1436-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 5, 2012
- FDA report date
- Aug 8, 2012
- Quantity
- 18,938 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1436-2012, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62407
- Address
- 311 Bonnie Cir
- Code information
- Lot #s: 412572A, 412572B, Exp 11/12
- Postal code
- 92880-2882
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1436-2012
- Classification
- Class III
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 18,938 cartons
- Termination date
- Mar 18, 2013
- Reason for recall
- Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2012