FDAClass IMay 18, 2022

SyrSpend SF Suspending Base recall: Sterility Concern

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

Why was SyrSpend SF Suspending Base recalled?

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

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 #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024

Product
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Recalling firm
Fagron, Inc
Quantity
a) 559 bottles and b) 243 bottles
Distribution
Nationwide USA and Puerto Rico, Canada, Columbia, France
Recall date
May 18, 2022
Classification
Class I
Status
Completed
Agency
FDA (drug)
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