The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0745-2019·Announced 2019-03-20

FDA Recalls Dr. King's SafeCare Rx ShinglePlex Skin Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx ShinglePlex Skin because it may be microbially contaminated. 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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

King Bio Inc. is recalling 268 bottles of Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL). The recall was initiated because the product is subject to microbial contamination. The affected product is identified by NDC 57955-7501-2 and UPC 357955750123.

The recall covers specific lots with the following expiration dates: 07/18 (Lot 070815J), 09/18 (Lot 091015G), 02/19 (Lot 021216F), 05/19 (Lot 052616M), and 08/19 (Lot 083016A). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and contact the recalling firm or a healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955750123, NDC 57955-7501-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
268

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: 070815J Exp. 07/18
  • 091015G Exp. 09/18
  • 021216F Exp. 02/19
  • 052616M Exp. 05/19
  • 083016A Exp. 08/19

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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