Fagron Compounding Services: Drug Recall
Recall #D-0125-2024 · 11/10/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-0125-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Fagron Compounding Services
- Status
- Ongoing
- Date Initiated
- 11/10/2023
- Location
- Wichita, KS, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756 bottles
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
Product Description
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
Distribution Pattern
Nationwide in the USA
Other Recalls by Fagron Compounding Services
- Class II: Risk 11/20/2025
- Class II: Risk 08/29/2025
- Class II: Risk 01/31/2025
- Class II: Risk 08/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.