D-0129-2019 Class II Terminated
FDA drug recall D-0129-2019 was initiated by Teva Pharmaceuticals USA on Oct 19, 2018 and is designated Class II. Reason for recall: Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 53,451 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2018
- Initiation Date
- Oct 19, 2018
- Termination Date
- Apr 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,451 bottles
Product Description
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Reason for Recall
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Distribution Pattern
U.S.A. Nationwide including Puerto Rico.
Code Information
Lot # 1220211M, Exp 02/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0129-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026