King Bio Recalls Skin Irritation Product Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Skin Irritations & Itch Relief 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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling Dr. King's SafeCare Rx Skin Irritations & Itch Relief, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 790 bottles of the product.
The affected product was distributed nationwide in the U.S.A., as well as in Canada and Australia. Specific lots involved include 080916V (Exp. 08/19), 010418C (Exp. 01/20), and 022616G (Exp. 02/19).
Consumers should stop using the product and check their lot numbers against the list provided. The FDA has classified this as a Class I recall.
The recalled product
- Product
- Dr. King's SafeCare Rx Skin Irritations & Itch Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-0177-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Medication
- Hazard
- Affected units
- 790
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 (3)
- Lots: 080916V Exp. 08/19
- 010418C Exp. 01/20
- 022616G Exp. 02/19
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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