SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to...
FDA Recall #D-0654-2016 — Class II — November 11, 2015
Product Description
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
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
44 Bottles
Distribution
Nationwide
Code Information
Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated