Drug Enforcement D-0661-2024

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

Status

Terminated

Classification

Class II

Report Date

October 2, 2024

Termination Date

January 29, 2025

Product Information

Product description
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Product quantity
27 bottles
Reason for recall
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to two medical facilities in MD and VA.

Location & Firm

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0661-2024
Event ID
95333
Recall initiation date
September 11, 2024
Center classification date
September 20, 2024
Code info
Lot # 476261, 479751, 479741, Exp 3/31/2026
More code info
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