FDA-Drug2022-02-02Class II

Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.

Edge Pharma, LLC
Hazard

CGMP Deviations

Sold states
nationwide
Affected count
114 bottles
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2022

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