D-0654-2016 Class II Terminated

Recalled by Fagron, Inc — Saint Paul, MN

Recall Details

Product Type
Drugs
Report Date
February 17, 2016
Initiation Date
November 11, 2015
Termination Date
August 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 Bottles

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.

Distribution Pattern

Nationwide

Code Information

Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406