D-0076-2023 Class II Terminated
FDA drug recall D-0076-2023 was initiated by B. Braun Medical, Inc. on Nov 25, 2022 and is designated Class II. Reason for recall: Lack of sterility assurance: Bags have the potential to leak. The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 756 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 25, 2022
- Termination Date
- Aug 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756 bags
Product Description
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Reason for Recall
Lack of sterility assurance: Bags have the potential to leak.
Distribution Pattern
FL, NJ, PA
Code Information
Lot: 0061832446 Exp. 31 Oct 2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0076-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026