D-145-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2013
- Initiation Date
- December 18, 2012
- Termination Date
- July 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,040 bottles
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.
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%).
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 512146A, Exp 01/31/2014