February 2018 FDA Recall Drug by Fagron, Inc (D-0547-2018 - Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).)

This Class II drug recall was voluntarily initiated by Fagron, Inc on February 14, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product; product contamination with yeast and mold (paecilomyces saturatus and aspergillus fumigatus).. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0547-2018

Reason for Recall
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Initiated
02-14-2018
Reported
03-07-2018
Quantity
a) 1007 bottles (500 mL) and b) 738 bottles (4 L)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79253
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2019
Product Description About Product Description
Full technical description of the product.
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120

Batch or Lot Expiration Information

Lot# a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020