FDA recall D-1388-2020

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

Reason for recall

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-12-26

Report date

2020-07-22

Termination date

2022-07-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1388-2020