Fagron, Inc: Drug Recall
Recall #D-0856-2022 · 03/04/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0856-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Fagron, Inc
- Status
- Completed
- Date Initiated
- 03/04/2022
- Location
- Saint Paul, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 559 bottles and b) 243 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Product Description
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Distribution Pattern
Nationwide USA and Puerto Rico, Canada, Columbia, France
Other Recalls by Fagron, Inc
- Class II: Risk 12/11/2023
- Class II: Risk 12/11/2023
- Class II: Risk 12/11/2023
- Class II: Risk 12/11/2023
- Class III: Low Risk 03/04/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.