ISSUE: Fagron is
recalling two lots, A67185 and A67186, of SyrSpend SF Cherry
because the affected lots are potentially contaminated with Burkholderia gladioli.
Burkholderia
gladioli is
an opportunistic pathogen most commonly affecting patients with
respiratory disease. Patients with compromised immune systems such as
those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also
can cause complications after transplants. Exposure to contaminated
product could lead to adverse events, which could be severe for at-risk
individuals. Fagron has received three complaints regarding an
undesirable smell associated with the product.
To date,
Fagron has not received any reports of adverse events related to the
product being recalled.
For more
information about this recall, click on the red button Read Recall below.
BACKGROUND: Fagron
sells this product for the extemporaneous compounding of prescriptions
for oral dosing.
RECOMMENDATIONS:
- Hospitals,
pharmacies, and distributors that possess affected product should
quarantine this material and await further instructions.
- Immediately
discontinue use or distribution of the recalled product.
- Consumers
should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using
this product.
- Consumers
with questions regarding this recall may contact Fagron Customer
Service.
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