Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Summary
The FDA issued a Class III for Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Man by Lupin Pharmaceuticals Inc.. Reason: Out-of-specification impurity test result observed at 18-month long term stability time point..
Details
Source
Drug Recall
External ID
D-0358-2022
Action Date
2022-01-12
Status
Terminated
Category
drug
Product Description
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Lot/Code Info: Lot # S000268, Exp. date January 2022
Quantity Affected: 23,965 100 count bottles
Reason for Recall
Out-of-specification impurity test result observed at 18-month long term stability time point.
Distribution
Product Distributed in NY and OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-29
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 77 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-0358-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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