Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:
Recalled July 22, 2020 · FDA recall D-1388-2020 · Akorn
Hazard
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample · FDA Class III
Units
33,343 bottles
Sold at
Nationwide USA and Puerto Rico
Description
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Product
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →