The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0707-2019·Announced 2019-03-20

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

King Bio Inc. is recalling Dr. King's SafeCare Rx Allergies Southwest U.S. due to microbial contamination. The recall covers 1,621 bottles 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 per the rubric.

Plain-English summary

King Bio Inc. is recalling 1,621 bottles of Dr. King's SafeCare Rx Allergies Southwest U.S., 2 fl. oz. (59 mL). The product is identified by NDC 57955-2715-2 and UPC 357955175025. The recall is due to microbial contamination.

The affected lots are 030818A (Exp. 03/20), 011416B (Exp. 01/19), and 111016B (Exp. 11/19). 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.

The recalled product

Product
Dr. King's SafeCare Rx Allergies Southwest U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-2715-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
1,621

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 (3)

  • Lots: 030818A Exp. 03/20
  • 011416B Exp. 01/19
  • 111016B 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 →

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