Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: B...

FDA Recall #D-0661-2024 — Class II — September 11, 2024

Recall #D-0661-2024 Date: September 11, 2024 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

27 bottles

Distribution

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

Code Information

Lot # 476261, 479751, 479741, Exp 3/31/2026

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated