Status
Terminated
Drug Enforcement D-1083-2023
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Classification
Class III
Report Date
August 16, 2023
Termination Date
July 7, 2025
Product Information
- 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
- Product quantity
- 43,812 bags
- Reason for recall
- Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States
Location & Firm
- Recalling firm
- B. Braun Medical Inc.
- Address
-
1845 Mason Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1083-2023
- Event ID
- 92797
- Recall initiation date
- August 2, 2023
- Center classification date
- August 8, 2023
- Code info
- Lot #: 0061852531, Exp 2/28/2025
- More code info
- —