Class III
Ongoing
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
This recall is currently active, issued December 6, 2023. It was issued by Fagron Compounding Services.
- Company
- Fagron Compounding Services
- Recall Initiated
- November 10, 2023
- Posted
- December 6, 2023
- Recall Number
- D-0125-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 756 bottles
- Firm Location
- Wichita, KS, United States
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
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