Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only,
Summary
The FDA issued a Class III for Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = by SCA Pharmaceuticals. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0363-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
Product Description
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Lot/Code Info: Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023
Quantity Affected: 2125 syringes
Reason for Recall
Subpotent Drug
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
Company
Windsor, CT
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 123 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
SCA Pharmaceuticals has 6 FDA actions in our database, including 6 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 (SCA Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SCA Pharmaceuticals have FDA actions?
SCA Pharmaceuticals has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0363-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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