Sodium Chloride 0.9% Injection recall: Sterility Concern
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC #…
Why was Sodium Chloride 0.9% Injection recalled?
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
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 # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
- Product
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC #…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 53,424 bags
- Distribution
- Product was distributed to 32 clinics in SC, NC and VA.
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)