Fagron Inc. has issued a voluntary nationwide recall of its over-the-counter (OTC) liquid medication SyrSpend SF Cherry due to the potential for microbial contamination. The recall affects two lots of SyrSpend SF Cherry and is carried out to the hospital, pharmacy, and distributor level.
The microbial Burkholderia gladioli is an opportunistic pathogen that can cause serious and sometimes fatal infections in individuals with weakened immune systems. Patients with Cystic Fibrosis have weakened immune system hence at higher risk.
Burkholderia gladioli can also cause complications to patients who have undergone transplants. The use of contaminated products can cause serious events to at-risk individuals. Fagron has received up to three complaints of undesirable smell coming from this product. To date, no illnesses have been reported to Fagron.
These products are sold for extemporaneous compounding of prescriptions for oral dosing. The affected lot numbers and expiry dates are listed below.
| Lot | Item number | Size | NDC number | Expiration date |
| A67185 | 805359 | 500 mL | 51552-1123-5 | 08/31/2024 |
| A67186 | 802496 | 4 L | 51551-1123-9 | 08/31/2024 |
Fagron has notified its distributors and consumers about the recall through letters, phone, and email. Distributors with the inventory of these products should stop the distribution and quarantine the affected products immediately.
Patients who have purchased SyrSpend SF Cherry are urged to discontinue its use immediately, return the product to their pharmacy. They should also contact their healthcare provider if they have experienced any adverse reactions associated with this product.
Fagron Inc. is working with Sedgwick to facilitate the recall.
Consumers with questions regarding the products can email Fagron at [email protected] or call 1-800-423-6967 from 9:00a.m. to 5:00p.m. Central Daylight Time, Monday through Friday. Any questions regarding the return of these products can contact Sedgwick by email at [email protected] or call 1-877-650-8362.
Any reports of the adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.
