The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0959-2019·Announced 2019-03-20

FDA Recalls Dr. King's Acute Pain Relief Cream Due to Microbial Contamination

King Bio Inc. is recalling 192 tubes of Dr. King's Acute Pain Relief Cooling Topical cream 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 source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall corresponds to a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's Acute Pain Relief Cooling Topical, 89 mL, manufactured by King Bio Inc. The recall involves 192 tubes of the product, identified by Lot 020417ZZ and an expiration date of 02/20. The product is being recalled due to microbial contamination.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. King Bio Inc. is the recalling firm for this action.

Consumers who have purchased this product should stop using it immediately and contact the manufacturer or their healthcare provider for further instructions. The FDA classifies this as a Class I recall, which is the most serious type of recall, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's Acute Pain Relief Cooling Topical, 89 mL (topical cream), Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80074489 UPC 357955181439
Manufacturer
King Bio Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
192

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: 020417ZZ Exp. 02/20

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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