FDA-Drug2018-03-07Class II

SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120

Fagron, Inc
Hazard

Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).

Sold states
Nationwide, USA
Affected count
a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
Manufactured in
2400 Pilot Knob Rd, N/A, Saint Paul, MN, United States
Products
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0547-2018

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