FDA recall D-197-2013

Humco Holding Group, Inc · Class II · drug

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.

Reason for recall

Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-01-17
Report date
2013-03-20
Termination date
2017-01-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Texarkana, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-197-2013