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Drug FDA Class II Terminated Quality

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

Mckesson Medical-Surgical Inc. Corporate Office Published Oct 2, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 45/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Mckesson Medical-Surgical Inc. Corporate Office or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

PROPARACAINE HYDROCHLORIDE · 27 bottles

NDC: 24208-730, 24208-730-06
Lot codes: 476261
Code info: Lot # 476261, 479751, 479741, Exp 3/31/2026

Affected areas

MarylandVirginia

Timeline

  1. Initiated
    Sep 11, 2024
  2. Published
    Oct 2, 2024
  3. Terminated
    Jan 29, 2025
Recall number
D-0661-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.