← FDA ENFORCEMENT
D-1083-2023Class III

B. Braun Medical Inc.

Recalling firm
B. Braun Medical Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-16
Distribution
United States
Firm state
FL
Product quantity
43,812 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Product description

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

Code / lot info

Lot #: 0061852531, Exp 2/28/2025

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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.