FDA-Drug2022-05-18Class I

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.

Fagron, Inc
Hazard

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

Sold states
Nationwide USA and Puerto Rico, Canada, Columbia, France
Affected count
a) 559 bottles and b) 243 bottles
Manufactured in
2400 Pilot Knob Rd, N/A, Saint Paul, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2022

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