November 2018 FDA Recall Drug by Avkare Inc.
D-0285-2019 - Microbial Contamination of Non-Sterile Product

This Class II drug recall was voluntarily initiated by Avkare Inc. on November 20, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed in WA only and the recall is currently terminated.

Recall Number: D-0285-2019

Reason for Recall
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Initiated
11-20-2018
Reported
12-05-2018
Quantity
1602 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81603
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.
AVKARE 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.
WA only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408

Batch or Lot Expiration Information

Lot# : 13417 Exp. 05/2020