SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspendin...
FDA Recall #D-0655-2016 — Class II — November 11, 2015
Product Description
SyrSpend SF, Suspending Base, Grape Flavored, 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 51552-1167-9.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Recalling Firm
Fagron, Inc — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
148 Bottles
Distribution
Nationwide
Code Information
Lot #s: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated