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.
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 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.
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