The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0697-2019·Announced 2019-03-20

King Bio Recalls Arnica Cream Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream due to microbial contamination.

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 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 I, which meets the rubric criteria for a severity score of 4 (Severe) or higher.

Plain-English summary

King Bio Inc. is recalling 3,536 tubes of Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g). The recall is being conducted due to microbial contamination. The product is a high-potency homeopathic formula intended for professional use only.

The affected lots are 010517ZZ (Exp. 01/20), 030818ZZ (Exp. 03/21), 040617ZZ (Exp. 04/20), 100616ZZ (Exp. 05/19), and 110916ZZ (Exp. 11/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should stop using the product and contact King Bio Inc. for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream High Potency Homeopathic Formula for Professional Use Only, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 USA, UPC 357955730132, NDC 57955-7301-3
Manufacturer
King Bio Inc.
Category
Drug — Topical Homeopathic Cream
Hazard
Affected units
3,536

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 (5)

  • Lots: 010517ZZ Exp. 01/20
  • 030818ZZ Exp. 03/21
  • 040617ZZ Exp. 04/20
  • 100616ZZ Exp. 05/19
  • 110916ZZ Exp. 11/19

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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