Proparacaine Hydrochloride Solution/ Drops
FDA Recall NDC 24208-730
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Proparacaine Hydrochloride (NDC 24208-730). A significant event, classified as Class II, was initiated on Sep 11, 2024 by Bausch & Lomb Incorporated. The reported reason for this action was: "Temperature abuse: Products exposed to improper temperature above drug label specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Sep 11, 2024
Oct 02, 2024
27 bottles
Recall Profile & Regulatory Data
Event ID
95333
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to two medical facilities in MD and VA.
Termination Date
Jan 29, 2025
Product Description
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
24208-730-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
