August 2023 FDA Recall Sodium Chloride by B. Braun Medical Inc.
D-1083-2023 - Labeling
This Class III drug recall was voluntarily initiated by B. Braun Medical Inc. on August 2, 2023 for the product Sodium Chloride. The FDA reported the reason for recall as labeling. The product was distributed in United States and the recall is currently terminated.
Recall Number: D-1083-2023
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
08-02-2023
08-16-2023
43,812 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States
07-07-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Batch or Lot Expiration Information
Lot# : 0061852531, Exp 2/28/2025
