FDAClass IIMarch 7, 2018

SyrSpend SF Suspending Base recall: Sterility Concern

SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120

Why was SyrSpend SF Suspending Base recalled?

Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).

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?

a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020

Product
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
Recalling firm
Fagron, Inc
Quantity
a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
Distribution
Nationwide, USA
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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