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.
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 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.
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