King Bio Recalls Homeopathic Sinus Relief for Microbial Contamination
King Bio Inc. is recalling specific lots of Dr. King's SafeCare Rx Sinus Relief 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.
Plain-English summary
King Bio Inc. is recalling 988 bottles of Dr. King's SafeCare Rx Sinus Relief High Potency Homeopathic Formula, 2 fl oz (59 mL). The recall is due to microbial contamination. The affected product is identified by NDC 57955-0134-2 and UPC 357955013426.
The recalled lots are 120816J (Expiration 12/19) and 123115C (Expiration 12/18). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should stop using the product and check their inventory for the specific lot numbers and expiration dates listed above. 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 Sinus Relief High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955013426, NDC 57955-0134-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 988
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 (2)
- Lots: 120816J Exp. 12/19
- 123115C Exp. 12/18
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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