FDA DrugsClass II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B...
Published: April 29, 2026Recall ID: D-0495-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product Description & Identification
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Additional Source Details
| Field | Value |
|---|---|
| City | Allentown |
| State | PA |
| Openfda › Unii | 059QF0KO0R |
| Openfda › Route | INTRAVENOUS |
| Openfda › Spl id | ed933e44-2560-495b-879c-99c6a0bf8ba0 |
| Openfda › Brand name | STERILE WATER |
| Openfda › Spl set id | 8924e52e-8622-4ed6-a061-1908183e0a18 |
| Openfda › Package ndc › 1 | 0264-7385-50 |
| Openfda › Package ndc › 2 | 0264-7385-60 |
| Openfda › Product ndc | 0264-7385 |
| Openfda › Generic name | WATER |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | WATER |
| Openfda › Manufacturer name | B. Braun Medical Inc. |
| Openfda › Application number | NDA019633 |
| Openfda › Is original packager | true |
| Event id | 98693 |
| Address 1 | 861 Marcon Blvd |
| Address 2 | N/A |
| Code info | Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. |
| Postal code | 18109-9577 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 24,928 bags |
| Reason for recall | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Overview
- Recalling FirmB BRAUN MEDICAL INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.