Drug 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
D-0547-2018
Product summary
- Firm
- Fagron, Inc
- Event
- Event 79253
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
- Official record key
drug-enforcement:D-0547-2018
Official wording
Reason: Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Code information: a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020
Distribution pattern: Nationwide, USA
Derived failure modes
-
Microbial contamination
Microbial contamination