SyrSpend SF recalled over sterility concerns

Recall date

November 11, 2015

Source

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

Official notice title

Fagron, Inc recalls SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assi…

Recall number

D-0656-2016

FDA classification

Class II

Brand / firm

Fagron, Inc

Sold / distributed

Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.

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 convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.