Dr. King's Advanced Arnica Recalled for Microbial Contamination
King Bio Inc. is recalling Dr. King's Advanced Arnica Super Arnica 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 FDA has classified this recall as Class I, which is the highest severity level for drug recalls, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling 199 tubes of Dr. King's Advanced Arnica Super Arnica, 59 mL, due to microbial contamination. The product is identified by Lot 050117ZZ and an expiration date of 05/20. It was manufactured by King Bio, Inc. and imported by Ambiental Solutions, Inc.
The recall covers distribution in the U.S.A. nationwide, Canada, and Australia. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls.
Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions on disposal or refund.
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 800774304 UPC 357955181330
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Medication
- Hazard
- Affected units
- 199
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: 050117ZZ Exp. 05/20
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.
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