The Recall Desk
CriticalFDA (Drugs)·D-0853-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Self-Abuse Due to Microbial Contamination

King Bio Inc. is recalling 104 bottles of Dr. King's SafeCare Rx Self-Abuse 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 corresponds to a Critical severity score per the rubric.

Plain-English summary

King Bio Inc. is recalling 104 bottles of Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-1071-2 and UPC 357955107026.

The recalled lots are 072815P (Exp. 07/18) and 111016D (Exp. 11/19). 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.

The recalled product

Product
Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955107026, NDC 57955-1071-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
104

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: 072815P Exp. 07/18
  • 111016D Exp. 11/19

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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