Drug product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
D-0661-2024
Product summary
- Event
- Event 95333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 bottles
- Official record key
drug-enforcement:D-0661-2024
Official wording
Reason: Temperature abuse: Products exposed to improper temperature above drug label specifications.
Code information: Lot # 476261, 479751, 479741, Exp 3/31/2026
Distribution pattern: Product was distributed to two medical facilities in MD and VA.
Derived failure modes
-
Unknown
Temperature abuse: Products exposed to improper temperature above drug label specifications.