January 2013 FDA Recall Drug by Humco Holding Group, Inc
D-197-2013 - Microbial Contamination of Non-Sterile Product(s

This Class II drug recall was voluntarily initiated by Humco Holding Group, Inc on January 17, 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-197-2013

Reason for Recall
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Initiated
01-17-2013
Reported
03-20-2013
Quantity
1,269,846 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64416
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.
Letter
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. 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; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco.

Batch or Lot Expiration Information

Lot# a) Good Neighbor, Item Number 163792006:
Lot# s: 534204, 538468, 540540; b) Quality Choice, Item Number 163792066:
Lot# s: 538835, 539431; c) Select Brands, Item Number 163792067:
Lot# : 540529; d) Premier Value, Item Number 163792079:
Lot# s: 534545 and 535307; e) CVS, Item Number 163791091 (1 oz.):
Lot# s 533472, 534055, 534256, 534546, 534995, 535249, 535318, 535683, 536302, 537285, 538138, 538189, 538439, 538672; and Item Number 163792091 (2 oz.):
Lot# s: 538408, 540530, 540542, 540712; f) Rite Aid, Item Number 163792088:
Lot# s: 533471, 534067, 534337, 534548, 535512, 535876, 536526, 537076, 537284, 538229, 538469, 538864, 539475, 540714, 541285, 541304, 541415, 541672; g) Top Care, Item Number 163792101:
Lot# : 535070, 535681, 537323, 537376, and 537587; h) H.E.B, Item Number 163793800:
Lot# s: 534442, 534701, 534981, 535332, 535403, 536300; and i) HUMCO, Item Number 163792001, 163792015 (2 oz.):
Lot# s 534612, 534767, 535402, 535845, 536899, 537335, 537586, 538219, 538470, 538865, 539691, 539803, 539845, 541193 and 533470, 533554, 534032, 534057, 534158, 534399, 534547, 534686, 535069, 535246, 535317, 535682, 535874, 536247, 536301, 536900, 537075, 537283, 537588, 537722, 537960, 538190, 538191, 538289, 538410, 538671, 538673, 539640, 539692, 540143, 540144, 540176, 540539, 540713, 540820, 540851, 541101, 541146, 541195, 541611, 541673; and Item Number 163793001 (3 oz.):
Lot# s: 534165, 534748, 535404, 537751, 539387, 540029, 540296, 540711.