FDA recall D-1048-2014

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. 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.

Reason for recall

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-11-26
Report date
2014-02-05
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-1048-2014