Fagron is voluntarily recalling 2 lots of SyrSpend SF Cherry due to a potential contamination with Burkholderia gladioli. The recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
SyrSpend SF Cherry is a syrup-suspending vehicle used in the preparation of oral liquid dose forms. The 2 affected lots are:
- Lot number A67185; Item number 805359; Size 500mL; NDC Number 51552-1123-5; Expiration Date August 31, 2024;
- Lot number A67186; Item number 802496; Size 4L; NDC Number 51551-1123-9; Expiration Date August 31, 2024.
To date, there have been no reports of adverse events related to these products and the recall is being carried out in an abundance of caution. The Company has received 3 complaints of undesirable smell associated with the product.
Burkholderia gladioli, a gram-negative bacteria, most commonly affects individuals with respiratory disease; those with compromised immune systems are at higher risk. The opportunistic pathogen can also cause complications in transplant patients.
Hospitals, pharmacies, and distributors are being asked to immediately discontinue use or distribution of the recalled product.
Questions specific to the return of the product should be directed to Sedgwick at 1-877-650-8362 or by email at [email protected]. Adverse events or quality problems may also be reported to the FDA’s MedWatch program.
Fagron Inc. Issues voluntary nationwide recall of SyrSpend SF Cherry due to microbial contamination. News release. Fagron. Accessed May 2, 2022. https://www.prnewswire.com/news-releases/fagron-inc-issues-voluntary-nationwide-recall-of-syrspend-sf-cherry-due-to-microbial-contamination-301536703.html