Agency classClass IIOur severity:Severe FDA (Drugs)·D-197-2013·Announced 2013-03-20

Humco Recalls Mercuroclear Antiseptic Anesthetic Due to Microbial Contamination Risk

Humco Holding Group is recalling Mercuroclear Antiseptic Anesthetic First Aid products due to potential contamination with Burkholderia gladioli. The recall covers 1,269,846 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk contamination scenarios.

Plain-English summary

Humco Holding Group, Inc. is recalling Mercuroclear Antiseptic Anesthetic First Aid products because they have the potential to be contaminated with Burkholderia gladioli. The product is a non-sterile first aid antiseptic and external analgesic containing benzalkonium chloride and lidocaine hydrochloride, intended to help prevent infection and relieve pain and itching from minor cuts, scrapes, burns, and insect bites.

The recall affects 1,269,846 bottles of the product, which were distributed nationwide. The affected products were sold under multiple brand names, including Good Neighbor Pharmacy, Quality Choice, Select Brand, Premier Value, CVS Pharmacy, Rite Aid Pharmacy, Top Care, HEB, and Humco. Specific lot numbers and item numbers for each brand are listed in the official recall notice.

Consumers who have purchased these products should stop using them and check the lot numbers on their bottles against the list provided in the recall notice. If the lot number matches, consumers should dispose of the product or return it to the place of purchase for a refund, as directed by the recalling firm.

The recalled product

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…
Manufacturer: Humco Holding Group, Inc
Category: Drug — Topical Antiseptic
Hazard: microbial-contamination
burkholderia-gladioli
Affected units: 1,269,846

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Humco Holding Group, Inc

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