May 2018 FDA Recall Drug by Inopak Ltd
D-0864-2018 - Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts

This Class II drug recall was voluntarily initiated by Inopak Ltd on May 16, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of nonsterile product; fda analysis returned out of specification results for total aerobic microbial counts. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0864-2018

Reason for Recall
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Initiated
05-16-2018
Reported
06-20-2018
Quantity
1345 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80196
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.
Inopak Ltd
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-23-2020
Product Description About Product Description
Full technical description of the product.
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ

Batch or Lot Expiration Information

Lot# 7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043