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
FDA recall notice · announced March 7, 2018 · Fagron
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Reason for recall
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Notes
Distribution: Nationwide, USA
Lot/code information: a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020
Quantity: a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
Status: Terminated
Products in this recall event:
- 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 (D-0547-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.