Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 0061852531, Exp 2/28/2025
Where it was sold
United States
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-1083-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 2, 2023
- FDA report date
- Aug 16, 2023
- Quantity
- 43,812 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc.
Original FDA data
Every field from FDA enforcement report D-1083-2023, exactly as published.
Show all FDA fields
- City
- Daytona Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 92797
- Address
- 1845 Mason Ave
- Code information
- Lot #: 0061852531, Exp 2/28/2025
- Postal code
- 32117-5102
- Report date
- Aug 16, 2023
- Product type
- Drugs
- Recall number
- D-1083-2023
- Classification
- Class III
- Recalling firm
- B. Braun Medical Inc.
- Product quantity
- 43,812 bags
- Termination date
- Jul 7, 2025
- Reason for recall
- Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- 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, NDC 0264-5802-00
- Distribution pattern
- United States
- Recall initiation date
- Aug 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2023