The Recall Desk
CriticalFDA (Drugs)·D-0708-2019·Announced 2019-03-20

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.

See all 465 products in this recall →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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