FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repa
Summary
The FDA issued a Class II for FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, by OurPharma LLC. Reason: Underfilled units..
Details
Source
Drug Recall
External ID
D-0078-2023
Action Date
2022-12-21
Status
Terminated
Category
drug
Product Description
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Lot/Code Info: Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.
Quantity Affected: 691 cassettes
Reason for Recall
Underfilled units.
Distribution
MO
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-29
Company
Fayetteville, AR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 29 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0078-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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