Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-c
Summary
The FDA issued a Class II for Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-c by Amerisource Health Services LLC. Reason: Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged.
Details
Source
Drug Recall
External ID
D-0269-2023
Action Date
2023-02-22
Status
Terminated
Category
drug
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
Lot/Code Info: Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Quantity Affected: (a) 6670 100-count (b) 2666 500-count bottles
Reason for Recall
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-11
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amerisource Health Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amerisource Health Services LLC have FDA actions?
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0269-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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