FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml ...
FDA Recall #D-0078-2023 — Class II — November 29, 2022
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
Reason for Recall
Underfilled units.
Recalling Firm
OurPharma LLC — Fayetteville, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
691 cassettes
Distribution
MO
Code Information
Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated