Drug product
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.
D-0856-2022
Product summary
- Firm
- Fagron, Inc
- Event
- Event 89805
- Status
- Completed
- Classification
- Class I
- Quantity
- a) 559 bottles and b) 243 bottles
- Official record key
drug-enforcement:D-0856-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Code information: Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Distribution pattern: Nationwide USA and Puerto Rico, Canada, Columbia, France
Derived failure modes
-
Microbial contamination
Microbial Contamination