Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti
Summary
The FDA issued a Class III for Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufacture by Lupin Pharmaceuticals Inc.. Reason: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study..
Details
Source
Drug Recall
External ID
D-0899-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Lot/Code Info: Lot #: A102887, Exp. 6/2023
Quantity Affected: 3,096 bottles
Reason for Recall
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Distribution
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-27
Company
Baltimore, MD
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0899-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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