D-0131-2020 Class III Terminated
FDA drug recall D-0131-2020 was initiated by Teva Pharmaceuticals USA on September 6, 2019 and is designated Class III. Reason for recall: GMP Deviation: lot not intended for commercial distribution. The recall status is terminated (terminated May 19, 2020). Affected quantity: 5,849 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- September 6, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,849 bottles
Product Description
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
Reason for Recall
GMP Deviation: lot not intended for commercial distribution.
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.
Code Information
Lot # 1344864A, exp. date 10/2020