The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0865-2019·Announced 2019-03-20

FDA Recalls King Bio Allergy Spray Due to Microbial Contamination

King Bio Inc. is recalling 80 bottles of Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S. nasal spray 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 per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL) nasal spray manufactured by King Bio Inc. The recall involves 80 bottles with Lot 073115E and an expiration date of 07/18. The product was distributed nationwide in the United States, as well as in Canada and Australia.

The recall was initiated due to microbial contamination. The FDA has classified this recall as Class I, which is the most serious classification indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Consumers who have purchased this specific lot of the product should stop using it immediately and contact King Bio Inc. or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955260325, NDC 57955-0062-2
Manufacturer
King Bio Inc.
Category
Drug — Nasal Spray
Hazard
Affected units
80

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 (1)

  • Lot: 073115E Exp. 07/18

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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