King Bio Recalls Dr. King's SafeCare Rx Calloused Due to Microbial Contamination
King Bio Inc. is recalling 4 bottles of Dr. King's SafeCare Rx Calloused 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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling 4 bottles of Dr. King's SafeCare Rx Calloused, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by Lot 063016C with an expiration date of 06/19.
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 who have this product should stop using it and contact King Bio Inc. for further instructions or a refund.
The recalled product
- Product
- Dr. King's SafeCare Rx Calloused, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955231028, NDC 57955-2311-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 4
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: 063016C Exp. 06/19
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.
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