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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sodium Chloride Injection Recalled for Missing Labeling

Agency Publication Date: August 8, 2023
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Summary

B. Braun Medical Inc. has recalled 43,812 bags of 0.9% Sodium Chloride Injection USP (1000 mL Excel Plus Container). The recall was initiated because some bags are missing critical information, including the product description, warnings, storage instructions, and directions for use, or have this information only partially printed. This medication was distributed nationwide to hospitals, clinics, and other healthcare facilities. No injuries or incidents have been reported to date.

Risk

The absence of complete warnings and instructions on the medication label could lead to improper storage or incorrect administration by healthcare providers. This poses a potential safety risk to patients, as the drug may not be used as intended or its efficacy could be compromised.

What You Should Do

  1. This recall affects B. Braun 0.9% Sodium Chloride Injection USP (1000 mL Excel Plus Container) with NDC 0264-5802-00.
  2. Identify affected units by checking for lot number 0061852531 with an expiration date of 2/28/2025 printed on the packaging.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Stop using and arrange return.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Injection USP (1000 mL)by B. Braun Medical Inc.
Variants: Excel Plus Container, Rx only
Lot Numbers:
0061852531 (Exp 2/28/2025)
NDC:
0264-5802-00

Labeling is either missing or partially printed.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92797
Status: Resolved
Manufacturer: B. Braun Medical Inc.
Sold By: hospitals; clinics; healthcare facilities
Manufactured In: United States
Units Affected: 43,812 bags
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.