The Recall Desk
CriticalFDA (Drugs)·D-0774-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx CS-Skin Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx CS-Skin 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 agency classification is FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Per the rubric, FDA Class I recalls are assigned a score of 5.

Plain-English summary

King Bio Inc. is recalling 57 bottles of Dr. King's SafeCare Rx CS-Skin, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0224-2 and UPC 357955021926.

The recall covers two specific lots: 120715B with an expiration date of 12/18, and 022616B with an expiration date of 02/19. The product was distributed nationwide in the United States, as well as in Canada and Australia.

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 CS-Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021926, NDC 57955-0224-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
57

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 (2)

  • Lots: 120715B Exp. 12/18
  • 022616B 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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