PlainRecalls
FDA Drug Critical Class I Completed

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.

Reported: May 18, 2022 Initiated: March 4, 2022 #D-0856-2022

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Fagron, Inc
Units Affected
a) 559 bottles and b) 243 bottles
Distribution
Nationwide USA and Puerto Rico, Canada, Columbia, France
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Fagron, Inc. Units affected: a) 559 bottles and b) 243 bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 18, 2022. Severity: Critical. Recall number: D-0856-2022.