Drug Enforcement D-0078-2023

Underfilled units.

Status

Terminated

Classification

Class II

Report Date

December 21, 2022

Termination Date

September 20, 2024

Product Information

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
Product quantity
691 cassettes
Reason for recall
Underfilled units.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
MO

Location & Firm

Recalling firm
OurPharma LLC
Address
2512 S City Lake Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0078-2023
Event ID
91229
Recall initiation date
November 29, 2022
Center classification date
December 9, 2022
Code info
Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.
More code info