SyrSpend SF Suspending Base recalled over sterility concerns

Recall date

March 4, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fagron, Inc recalls SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51…

Recall number

D-0856-2022

FDA classification

Class I

Brand / firm

Fagron, Inc

Sold / distributed

Nationwide USA and Puerto Rico, Canada, Columbia, France

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.