November 2022 FDA Recall Drug by Ourpharma Llc
D-0078-2023 - Underfilled units.

This Class II drug recall was voluntarily initiated by Ourpharma Llc on November 29, 2022 for the product Drug. The FDA reported the reason for recall as underfilled units.. The product was distributed in MO and the recall is currently terminated.

Recall Number: D-0078-2023

Reason for Recall
Underfilled units.
Initiated
11-29-2022
Reported
12-21-2022
Quantity
691 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91229
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
OurPharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-20-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.