Multi event Drug Recall Enforcement Report Class I voluntary initiated by B BRAUN MEDICAL INC, originally initiated on 08-18-2025 for the product 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 The product was recalled due to presence of particulate matter.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0628-2025 | 08-18-2025 | 09-10-2025 | Class I | 47,148 containers | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 | Presence of Particulate Matter. | Ongoing |
| D-0627-2025 | 08-18-2025 | 09-10-2025 | Class I | 46,032 containers | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 | Presence of Particulate Matter | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0264-7750 | Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7750 | Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7800 | Sodium Chloride | | | | B. Braun Medical Inc. | |
| 0264-7800 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7800 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
