July 2024 FDA Recall Sodium Chloride by B. Braun Medical Inc
D-0638-2024 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by B. Braun Medical Inc on July 24, 2024 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0638-2024

Reason for Recall
Presence of Particulate Matter
Initiated
07-24-2024
Reported
08-28-2024
Quantity
63,444 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95035
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
B. Braun Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within U.S.A
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0264-7800-09 Sodium Chloride