CLASS II Drug recall · Reported 2 Oct 2024 · FDA Enforcement Report
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile) recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), distributed in Maryland, Virginia. The recall was initiated on 11 Sep 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0661-2024
- FDA event ID
- 95333
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Manufacturer
- Bausch & Lomb Incorporated
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2024
- FDA classified
- 20 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Eye Drops
Timeline
| 11 Sep 2024 | Recall initiated by company | |
| 20 Sep 2024 | Classified by FDA | +9 days |
| 2 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Where it was distributed
Product was distributed to two medical facilities in MD and VA.
Questions about this recall
Why was it recalled?
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Which lots are affected?
Lot # 476261, 479751, 479741, Exp 3/31/2026
Where was it sold?
Product was distributed to two medical facilities in MD and VA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
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|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Proparacaine recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proparacaine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% per dropper recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |