FDAClass IIFebruary 5, 2014

Aminosyn 3.5% M Sulfite-Free recall: Sterility Concern

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc…

Why was Aminosyn 3.5% M Sulfite-Free recalled?

Lack of Assurance of Sterility; potential leakage from administrative 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 #: 26-123-JT, Exp: 8/14

Product
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc…
Recalling firm
Hospira Inc.
Quantity
15258 bags
Distribution
Nationwide including Puerto Rico
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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