FDA-Drug2020-07-22Class III
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Akorn, Inc.
Hazard
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Sold states
Nationwide USA and Puerto Rico
Affected count
33,343 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1388-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief