The Recall Desk
CriticalFDA (Drugs)·D-0782-2019·Announced 2019-03-20

King Bio Recalls Urinary Tract Infection Product Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Urinary Tract Infections 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 recalling Dr. King's SafeCare Rx Urinary Tract Infections, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 557 bottles of the product, which is identified by UPC 357955005223 and NDC 57955-0052-2.

The affected lots include 072815J (Exp. 07/18), 030916Y (Exp. 03/19), 110716B (Exp. 11/19), and 101317J (Exp. 10/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The 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 Urinary Tract Infections, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955005223, NDC 57955-0052-2
Manufacturer
King Bio Inc.
Category
Drug — Urinary Tract Infection
Hazard
Affected units
557

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 (4)

  • Lots: 072815J Exp. 07/18
  • 030916Y Exp. 03/19
  • 110716B Exp. 11/19
  • 101317J Exp. 10/19

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

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Same hazard · microbial contamination

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