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
Reported: March 7, 2018 Initiated: February 14, 2018 #D-0547-2018
Product Description
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).
Details
- Recalling Firm
- Fagron, Inc
- Units Affected
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
- Distribution
- Nationwide, USA
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fagron, Inc. Units affected: a) 1007 bottles (500 mL) and b) 738 bottles (4 L).
Why was this product recalled? ▼
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Moderate. Recall number: D-0547-2018.
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