D-0547-2018 Class II Terminated
FDA drug recall D-0547-2018 was initiated by Fagron, Inc on February 14, 2018 and is designated Class II. Reason for recall: Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus). The recall status is terminated (terminated September 10, 2019). Affected quantity: a) 1007 bottles (500 mL) and b) 738 bottles (4 L).
Recall Details
- Product Type
- Drugs
- Report Date
- March 7, 2018
- Initiation Date
- February 14, 2018
- Termination Date
- September 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
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).
Distribution Pattern
Nationwide, USA
Code Information
a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020