Proparacaine Hydrochloride Ophthalmic Solution recall
FDA recall D-0661-2024 · initiated Sep 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office recalled Proparacaine Hydrochloride Ophthalmic Solution in Sep 2024 — an FDA Class II recall (D-0661-2024) because Temperature abuse: Products exposed to improper temperature above drug label specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 27 bottles
Details
- Product
- Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
- Recalling company
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to two medical facilities in MD and VA.
- Initiated
- Sep 11, 2024
- FDA report date
- Oct 2, 2024
Frequently asked
- Was Proparacaine Hydrochloride Ophthalmic Solution recalled?
- Mckesson Medical-Surgical Inc. Corporate Office recalled Proparacaine Hydrochloride Ophthalmic Solution in Sep 2024 — an FDA Class II recall (D-0661-2024) because Temperature abuse: Products exposed to improper temperature above drug label specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Proparacaine Hydrochloride Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0661-2024 was: Temperature abuse: Products exposed to improper temperature above drug label specifications.
- Is a recalled Proparacaine Hydrochloride Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Proparacaine Hydrochloride Ophthalmic Solution are affected?
- Distributed: Product was distributed to two medical facilities in MD and VA.. The recall covers these lots — Lot # 476261, 479751, 479741, Exp 3/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0661-2024.