Drug Enforcement D-0638-2024

Presence of Particulate Matter

Status

Ongoing

Classification

Class I

Report Date

August 28, 2024

Termination Date

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Product Information

Product description
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Product quantity
63,444 containers
Reason for recall
Presence of Particulate Matter
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within U.S.A

Location & Firm

Recalling firm
B. Braun Medical Inc
Address
2525 Mcgaw Ave

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

Codes & Dates

Recall number
D-0638-2024
Event ID
95035
Recall initiation date
July 24, 2024
Center classification date
August 19, 2024
Code info
Lot #: J2L763, J2L764, Exp: 31 March 2025
More code info
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