Status
Ongoing
Drug Enforcement D-0125-2024
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
Classification
Class III
Report Date
December 6, 2023
Termination Date
—
Product Information
- 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
- 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
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Fagron Compounding Services
- Address
-
8710 E 34th St N
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0125-2024
- Event ID
- 93453
- Recall initiation date
- November 10, 2023
- Center classification date
- November 28, 2023
- Code info
- Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
- More code info
- —