D-0655-2016 Class II Terminated
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
- 148 Bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot #s: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277