Sterile Water for Injection USP recall: Sterility Concern
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.
Why was Sterile Water for Injection USP recalled?
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
- Product
- 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.
- Recalling firm
- B BRAUN MEDICAL INC
- Quantity
- 24,928 bags
- Distribution
- US Nationwide.
- Recall date
- April 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)