0.9% Sodium Chloride Injection USP recall: Sterility Concern
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Why was 0.9% Sodium Chloride Injection USP recalled?
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 #: 49-084-JT; 49-119-JT
- Product
- 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
- Recalling firm
- Hospira Inc.
- Quantity
- 314600 bags
- Distribution
- United States
- Recall date
- July 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)