Drug product
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.
D-145-2013
Product summary
- Event
- Event 64056
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,040 bottles
- Official record key
drug-enforcement:D-145-2013
Official wording
Reason: 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%).
Code information: Lot #: 512146A, Exp 01/31/2014
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification