FDA-Drug2021-06-02Class II

RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
3688 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2021

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