D-1303-2022 Class II Terminated
FDA drug recall D-1303-2022 was initiated by Teva Pharmaceuticals USA Inc on Jul 21, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications: below specification limits for dissolution. The recall status is terminated (terminated Apr 18, 2023). Affected quantity: 5677 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 10, 2022
- Initiation Date
- Jul 21, 2022
- Termination Date
- Apr 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5677 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: below specification limits for dissolution.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot 1411596A, Exp 09/22
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1303-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026