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Recall Observatory FDA recall evidence

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

September 06, 2019

Class III

Product summary

Firm
Teva Pharmaceuticals USA
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

    reason.manufacturing_process_control · v1.0.0

    GMP Deviation