Recalls / Class II
Class IID-0547-2018
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
- Affected lot / code info
- a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020
Why it was recalled
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
- Distribution pattern
- Nationwide, USA
Timeline
- Recall initiated
- 2018-02-14
- FDA classified
- 2018-02-27
- Posted by FDA
- 2018-03-07
- Terminated
- 2019-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0547-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.