September 2024 FDA Recall Proparacaine Hydrochloride by Mckesson Medical-surgical Inc. Corporate Office
D-0661-2024 - Temperature abuse

This Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on September 11, 2024 for the product Proparacaine Hydrochloride. The FDA reported the reason for recall as temperature abuse. The product was distributed in Product was distributed to two medical facilities in MD and VA. and the recall is currently terminated.

Recall Number: D-0661-2024

Reason for Recall
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Initiated
09-11-2024
Reported
10-02-2024
Quantity
27 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95333
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two medical facilities in MD and VA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2025
Product Description About Product Description
Full technical description of the product.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

24208-730-06 Proparacaine Hydrochloride