The Recall Desk
CriticalFDA (Drugs)·D-0726-2019·Announced 2019-03-20

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

King Bio Inc. is recalling Dr. King's SafeCare Rx Wounds Recovery 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 meets the rubric criteria for a Critical severity score (5).

Plain-English summary

King Bio Inc. is voluntarily recalling 388 bottles of Dr. King's SafeCare Rx Wounds Recovery, 2 fl. oz. (59 mL). The recall is being conducted because the product is subject to microbial contamination. The affected product is identified by NDC 57955-0118-2 and UPC 357955011828.

The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. The specific lots involved are 081815M (expiration date 08/18) and 012017B (expiration date 01/20).

Consumers who have this product should stop using it and contact King Bio Inc. for further instructions or a refund. The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Wounds Recovery, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955011828, NDC 57955-0118-2
Manufacturer
King Bio Inc.
Category
Drug — Topical Wound Care
Hazard
Affected units
388

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: 081815M Exp. 08/18
  • 012017B Exp. 01/20

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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