The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0960-2019·Announced 2019-03-20

King Bio Recalls Advanced Arnica Super Arnica Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Advanced Arnica Super Arnica, 59 mL, due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling Dr. King's Advanced Arnica Super Arnica, 59 mL, due to microbial contamination. The recall involves 1,110 bottles of the product, which is identified by Lot 013117P and an expiration date of 01/20. The product was manufactured by King Bio, Inc. in Asheville, NC, and imported by Ambiental Solutions, Inc. in Vancouver, BC.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The recall is classified as Class I by the U.S. Food and Drug Administration.

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The specific hazard is identified as microbial contamination.

The recalled product

Product
Dr. King's Advanced Arnica Super Arnica, 59 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 800774305 UPC 357955181224
Manufacturer
King Bio Inc.
Affected units
1,110

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 (1)

  • Lot: 013117P Exp. 01/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 465 products in this recall →

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