January 2023 FDA Recall Drug by Ourpharma Llc
D-0172-2023 - Short Fill

This Class III drug recall was voluntarily initiated by Ourpharma Llc on January 13, 2023 for the product Drug. The FDA reported the reason for recall as short fill. The product was distributed in IL and MO and the recall is currently terminated.

Recall Number: D-0172-2023

Reason for Recall
Short Fill: Underfilled units.
Initiated
01-13-2023
Reported
02-01-2023
Quantity
768 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91520
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
IL and 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 2.5mg/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.

Batch or Lot Expiration Information

Lot# Lots: 100122080003, Exp. 2/26/2023; 100122090001, Exp. 3/07/2023; 100122100002, Exp. 4/05/2023