March 2022 FDA Recall Drug by Fagron, Inc
D-0856-2022 - Microbial Contamination of Non-Sterile Product
This Class I drug recall was voluntarily initiated by Fagron, Inc on March 4, 2022 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0856-2022
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
03-04-2022
05-18-2022
a) 559 bottles and b) 243 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Puerto Rico, Canada, Columbia, France
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : a) A67185, Exp. Date 08/31/2024; b)
Lot# : A67186, Exp. Date 08/31/2024
