Drug product
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30
D-0131-2020
Product summary
- Event
- Event 83730
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,849 bottles
- Official record key
drug-enforcement:D-0131-2020
Official wording
Reason: GMP Deviation: lot not intended for commercial distribution.
Code information: Lot # 1344864A, exp. date 10/2020
Distribution pattern: Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
GMP Deviation