Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208
Summary
The FDA issued a Class II for Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle by Mckesson Medical-Surgical Inc. Corporate Office. Reason: Temperature abuse: Products exposed to improper temperature above drug label specifications..
Details
Source
Drug Recall
External ID
D-0661-2024
Action Date
2024-10-02
Status
Terminated
Category
drug
Product Description
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Lot/Code Info: Lot # 476261, 479751, 479741, Exp 3/31/2026
Quantity Affected: 27 bottles
Reason for Recall
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Distribution
Product was distributed to two medical facilities in MD and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-11
Company
Richmond, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0661-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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