SyrSpend SF Suspending Base recalled over sterility concerns

Recall date

February 14, 2018

Source

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

Official notice title

Fagron, Inc recalls SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagro…

Recall number

D-0547-2018

FDA classification

Class II

Brand / firm

Fagron, Inc

Sold / distributed

Nationwide, USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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