January 2025 FDA Recall Drug by Fagron Compounding Services
D-0225-2025 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Fagron Compounding Services on January 31, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Distributed in PA and the recall is currently completed.

Recall Number: D-0225-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-31-2025
Reported
02-26-2025
Quantity
1330 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96232
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron Compounding Services
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.
Distributed in PA
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Batch or Lot Expiration Information

Lot# C274-000040409, Exp 03/22/2025