Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pha
Summary
The FDA issued a Class III for Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottl by Akorn, Inc.. Reason: Labeling: Missing Label.
Details
Source
Drug Recall
External ID
D-0368-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
Product Description
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Lot/Code Info: Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
Quantity Affected: 8184 bottles
Reason for Recall
Labeling: Missing Label
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-03
Company
Lake Forest, IL
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 66 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Akorn, Inc. has 130 FDA actions in our database, including 130 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 (Akorn, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akorn, Inc. have FDA actions?
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0368-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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