November 2013 FDA Recall Drug by Humco Holding Group, Inc
D-1048-2014 - Microbial Contamination of Non-Sterile Product(s

This Class II drug recall was voluntarily initiated by Humco Holding Group, Inc on November 26, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product(s). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1048-2014

Reason for Recall
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Initiated
11-26-2013
Reported
02-05-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66927
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.
Humco Holding Group, 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2017
Product Description About Product Description
Full technical description of the product.
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501.

Batch or Lot Expiration Information

Lot# a) Good Neighbor Pharmacy Mercuroclear 2 fl. oz, Lots: ALL LOTS b) Quality Choice Mercuroclear 2 fl. oz, Lots: ALL LOTS c) Select Brand Mercuroclear 2 fl. oz, Lots: ALL LOTS d) Premier Value Mercuroclear 2 fl. oz, Lot: ALL LOTS e) Rite Aid Mercuroclear 2 fl. oz, Lots: ALL LOTS f) Top Care Mercuroclear 2 fl. oz , Lots: ALL LOTS g) Vida Mia Mercuroclear, 2 fl. oz. Lots: ALL LOTS h) HUMCO Mercuroclear 2 fl oz. sold to WalMart Lots: ALL LOTS i) HUMCO Mercuroclear 3 fl. oz. Lots: ALL LOTS