The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0881-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Shy Due to Microbial Contamination

King Bio Inc. is recalling 13 bottles of Dr. King's SafeCare Rx Shy 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 per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

King Bio Inc. is recalling 13 bottles of Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by Lot 091616F with an expiration date of 09/19, UPC 357955275022, and NDC 57955-2751-2.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Consumers who have this product should stop using it immediately and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955275022, NDC 57955-2751-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
13

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: 091616F Exp. 09/19

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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