The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0855-2019·Announced 2019-03-20

FDA Recalls Dr. King's SafeCare Rx CS-Pain Reliever Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx CS-Pain Reliever 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 agency classification is FDA Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's SafeCare Rx CS-Pain Reliever, 2 fl. oz. (59 mL), manufactured by King Bio Inc. The recall is due to microbial contamination. The affected product has the NDC 57955-0217-2 and UPC 357955021728.

The recall involves 38 bottles from two specific lots: Lot 071116H with an expiration date of 07/19, and Lot 122216C with an expiration date of 12/19. 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 they possess the affected product, they should stop using it and contact King Bio Inc. or their healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx CS-Pain Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021728, NDC 57955-0217-2
Manufacturer
King Bio Inc.
Category
Drug — Topical Pain Reliever
Hazard
Affected units
38

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: 071116H Exp. 07/19
  • 122216C Exp. 12/19

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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