Fagron Inc. Voluntarily Recalls SyrSpend SF Cherry Due to Microbial Contamination

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

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.

 

Got a Legal Issue? Let Us Help You Find An Attorney Near You

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.

Legal Giant is not a law firm and does not offer legal services.  We are a lawyer network platform that provides you access to hundreds of highly skilled attorneys in your area.  Our primary objective is to help you find a specialist lawyer for your case as fast as possible. We focus on practice area expertise and jurisdiction to offer you the best service possible.  Any information provided on this site is not legal advice, does not constitute a lawyer referral service, and no attorney-client or confidential relationship is or will be formed by the use of our site.

Leave a Comment

Scroll to Top

Legal Giant’s mission is to connect you with highly experienced attorneys when you need legal help, just like it’s our own family.Our team of experienced writers and legal editors is fully committed to providing high-quality content and accurate information.

Our content is fact checked and approved by our team of editors and practicing attorneys. Should you find an error within any of our website content, please feel free to contact us and let us know.

Tell us about your case to get started.