← FDA ENFORCEMENT
D-0638-2024Class I

B. Braun Medical Inc

Recalling firm
B. Braun Medical Inc
Product type
Drug
Status
Ongoing
Report date
2024-08-28
Distribution
Nationwide within U.S.A
Firm state
CA
Product quantity
63,444 containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter

Product description

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

Code / lot info

Lot #: J2L763, J2L764, Exp: 31 March 2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.