Recalling firm
Fagron Compounding Services
Product type
Drug
Status
Ongoing
Report date
2023-12-06
Distribution
Nationwide in the USA
Firm state
KS
Product quantity
756 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason 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
Code / lot info
Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.