Recalls / Class II
Class IID-0661-2024
Product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
- Brand name
- Proparacaine Hydrochloride
- Generic name
- Proparacaine Hydrochloride
- Active ingredient
- Proparacaine Hydrochloride
- Route
- Ophthalmic
- NDC
- 24208-730
- FDA application
- ANDA040074
- Affected lot / code info
- Lot # 476261, 479751, 479741, Exp 3/31/2026
Why it was recalled
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Bausch & Lomb Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 27 bottles
- Distribution pattern
- Product was distributed to two medical facilities in MD and VA.
Timeline
- Recall initiated
- 2024-09-11
- FDA classified
- 2024-09-20
- Posted by FDA
- 2024-10-02
- Terminated
- 2025-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0661-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.