D-0856-2022 Class I

Recalled by Fagron, Inc — Saint Paul, MN

Recall Details

Product Type
Drugs
Report Date
May 18, 2022
Initiation Date
March 4, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 559 bottles and b) 243 bottles

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.

Reason for Recall

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Distribution Pattern

Nationwide USA and Puerto Rico, Canada, Columbia, France

Code Information

Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024