Why it was recalled
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Product description
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
Lot numbers, UPCs & expiration codes
Lot #: 512146A, Exp 01/31/2014
Where it was sold
Nationwide and Puerto Rico
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-145-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 18, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 3,040 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-145-2013, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64056
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 512146A, Exp 01/31/2014
- Postal code
- 07054-1120
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-145-2013
- Classification
- Class II
- Recalling firm
- Watson Pharmaceuticals
- Product quantity
- 3,040 bottles
- Termination date
- Jul 30, 2014
- Reason for recall
- Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 18, 2012
- Initial firm notification
- Center classification date
- Feb 4, 2013