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Recall Observatory FDA recall evidence

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

September 11, 2024

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
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

    reason.no_named_rule · v1.0.0

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