FDA DrugsClass II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical In...
Published: April 29, 2026Recall ID: D-0496-2026Category: 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
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Additional Source Details
| Field | Value |
|---|---|
| City | Allentown |
| State | PA |
| Openfda › Unii | IY9XDZ35W2 |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui | 237656 |
| Openfda › Spl id | 200c4b9e-283a-4dea-b33a-9bb4936b2b99 |
| Openfda › Brand name | DEXTROSE |
| Openfda › Spl set id | 8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0 |
| Openfda › Package ndc | 0264-7387-50 |
| Openfda › Product ndc | 0264-7387 |
| Openfda › Generic name | DEXTROSE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DEXTROSE |
| Openfda › Manufacturer name | B. Braun Medical Inc. |
| Openfda › Application number | NDA019626 |
| Openfda › Is original packager | true |
| Event id | 98693 |
| Address 1 | 861 Marcon Blvd |
| Address 2 | N/A |
| Code info | Lot # J5H166, J5H167, Exp Date: 30NOV2026. |
| Postal code | 18109-9577 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 17,124 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.