Proparacaine Hydrochloride Ophthalmic Solution recalled over temperature-control failures

Recall date

September 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mckesson Medical-Surgical Inc. Corporate Office recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 2420…

Recall number

D-0661-2024

FDA classification

Class II

Brand / firm

Mckesson Medical-Surgical Inc. Corporate Office

Sold / distributed

Product was distributed to two medical facilities in MD and VA.

Why it was recalled

Temperature abuse: Products exposed to improper temperature above drug label specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06