November 2023 FDA Recall Drug by Fagron Compounding Services
D-0125-2024 - Labeling

This Class III drug recall was voluntarily initiated by Fagron Compounding Services on November 10, 2023 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0125-2024

Reason for Recall
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Initiated
11-10-2023
Reported
12-06-2023
Quantity
756 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93453
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.
Ongoing
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01

Batch or Lot Expiration Information

Lot# : C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024