Class II Recall

B BRAUN MEDICAL INC

Product
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Classification
Class II
Status
Ongoing
Lot
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.