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Class II: temporary or reversible health riskTerminated

B. Braun Medical 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Med…

B. Braun Medical Inc. · Daytona Beach, FL

Risk level
Class II
Reported by FDA
Jul 19, 2023
Recall ID
D-0916-2023
Check your lot numberHow we source this data

Summary

B. Braun Medical recalled 0.9% Sodium Chloride Injection starting Jul 5, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0916-2023 on Jul 19, 2023. Reason: Lack of assurance of sterility: bags have the potential to leak. Status: Terminated.

Why it was recalled

Lack of assurance of sterility: bags have the potential to leak.

Product description

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

Lot numbers, UPCs & expiration codes

Lot#: 0061858305, 0061858306 Exp 3/31/2025

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0916-2023
Classification
Class II
Status
Terminated
Recall initiated
Jul 5, 2023
FDA report date
Jul 19, 2023
Quantity
79,880 bags
Recall type
Voluntary: Firm initiated
Recalling firm
B. Braun Medical Inc.

Original FDA data

Every field from FDA enforcement report D-0916-2023, exactly as published.

Show all FDA fields
City
Daytona Beach
State
FL
Status
Terminated
Country
United States
Event ID
92640
Address
1845 Mason Ave
Code information
Lot#: 0061858305, 0061858306 Exp 3/31/2025
Postal code
32117-5102
Report date
Jul 19, 2023
Product type
Drugs
Recall number
D-0916-2023
Classification
Class II
Recalling firm
B. Braun Medical Inc.
Product quantity
79,880 bags
Termination date
Apr 23, 2024
Reason for recall
Lack of assurance of sterility: bags have the potential to leak.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Distribution pattern
USA Nationwide
Recall initiation date
Jul 5, 2023
Initial firm notification
Letter
Center classification date
Jul 13, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0916-2023, published Jul 19, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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