Recalls / Class III
Class IIID-0125-2024
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
- Affected lot / code info
- Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
Why it was recalled
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
Recalling firm
- Firm
- Fagron Compounding Services
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 8710 E 34th St N, Wichita, Kansas 67226-2636
Distribution
- Quantity
- 756 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-10
- FDA classified
- 2023-11-28
- Posted by FDA
- 2023-12-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.