COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason Description
Potential contamination with Burkholderia gladioli
- Company Name:
- Fagron Inc.
- Brand Name:
- Product Description:
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Product Description
Company Announcement
FOR IMMEDIATE RELEASE – 04/29/2022 – St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. 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.
Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. The affected lots with expiration 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 already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please 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.
Fagron has contracted with Sedgwick to facilitate this recall. Consumers with questions regarding this recall may contact Fagron Customer Service at 1-800-423-6967 from 9:00a.m. to 5:00p.m. Central Daylight Time, Monday through Friday, or by email at customer.service@fagron.us. Questions specific to the return of product should be directed to Sedgwick at 1-877-650-8362 or by email at fagron4043@sedgwick.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
