Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal
Summary
The FDA issued a Class II for Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count b by Amneal Pharmaceuticals of New York, LLC. Reason: Failed dissolution specifications..
Details
Source
Drug Recall
External ID
D-1362-2022
Action Date
2022-08-31
Status
Terminated
Category
drug
Product Description
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Lot/Code Info: Lot #: AR210705, Exp 04/2024
Quantity Affected: 4,309 bottles
Reason for Recall
Failed dissolution specifications.
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Brookhaven, NY
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 131 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 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 (Amneal Pharmaceuticals of New York, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals of New York, LLC have FDA actions?
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1362-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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