Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K
Summary
The FDA issued a Class III for Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescriptio by Fagron, Inc. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0863-2022
Action Date
2022-05-18
Status
Terminated
Category
drug
Product Description
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
Lot/Code Info: Lot #: 18H02-U02-044978, 18L12-U02-050018, Exp. Date 10/31/2022 18L12-U02-000952, Exp. Date Sep 2023
Quantity Affected: 53 containers
Reason for Recall
Subpotent Drug
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
Saint Paul, MN
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 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fagron, Inc has 10 FDA actions in our database, including 10 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 (Fagron, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fagron, Inc have FDA actions?
Fagron, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0863-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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