FDA recall D-0856-2022

Product

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

Reason for recall

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Distribution

Nationwide USA and Puerto Rico, Canada, Columbia, France

Key facts

Status

Completed

Initiation date

2022-03-04

Report date

2022-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2022