Drug product
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
D-1303-2022
Product summary
- Event
- Event 90635
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5677 bottles
- Official record key
drug-enforcement:D-1303-2022
Official wording
Reason: Failed Dissolution Specifications: below specification limits for dissolution.
Code information: Lot 1411596A, Exp 09/22
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications