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Recall Observatory FDA recall evidence

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.

D-1048-2014

November 26, 2013

Class II

Product summary

Firm
Humco Holding Group, Inc
Event
Event 66927
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1048-2014

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination