FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPha
Summary
The FDA issued a Class III for FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV by OurPharma LLC. Reason: Short Fill: Underfilled units..
Details
Source
Drug Recall
External ID
D-0172-2023
Action Date
2023-02-01
Status
Terminated
Category
drug
Product Description
FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
Lot/Code Info: Lots: 100122080003, Exp. 2/26/2023; 100122090001, Exp. 3/07/2023; 100122100002, Exp. 4/05/2023
Quantity Affected: 768 cassettes
Reason for Recall
Short Fill: Underfilled units.
Distribution
IL and MO
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-13
Company
Fayetteville, AR
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 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
OurPharma LLC has 3 FDA actions in our database, including 3 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 (OurPharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OurPharma LLC have FDA actions?
OurPharma LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0172-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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