August 2016 FDA Recall Drug by Sperian Eye & Face Protection, Inc
D-0216-2017 - Non Sterility; contaminated with Klebsiella pneumoniae

This Class I drug recall was voluntarily initiated by Sperian Eye & Face Protection, Inc on August 16, 2016 for the product Drug. The FDA reported the reason for recall as non sterility; contaminated with klebsiella pneumoniae. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0216-2017

Reason for Recall
Non Sterility; contaminated with Klebsiella pneumoniae
Initiated
08-16-2016
Reported
12-28-2016
Quantity
9,744 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74878
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sperian Eye & Face Protection, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2019
Product Description About Product Description
Full technical description of the product.
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818

Batch or Lot Expiration Information

Lot# Lot number: F16091-61, exp 03/2019 Product Codes: 32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, 32-000462-0036