FDAClass IIJanuary 18, 2017

10% Premasol sulfite-free recall

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield…

Why was 10% Premasol sulfite-free recalled?

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

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 #: P333617, Exp 4/30/17

Product
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield…
Recalling firm
Baxter Healthcare Corporation
Quantity
3,528 eaches
Distribution
US
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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