King Bio Recalls Bed Wetting Prevention Formula Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Bed Wetting Prevention Children High Potency Homeopathic Formula due to microbial contamination.
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 mandates a severity score of 5 according to the rubric.
Plain-English summary
King Bio Inc. is recalling 45 bottles of Dr. King's SafeCare Rx Bed Wetting Prevention Children High Potency Homeopathic Formula for Professional Use Only. The product is a 2 fl. oz. (59 mL) liquid formula manufactured by King Bio Inc. in Asheville, NC.
The recall was initiated because the product is subject to microbial contamination. The affected lot is 102216B with an expiration date of 08/2018. The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers who have this product should stop using it and contact King Bio Inc. for further instructions or a refund.
The recalled product
- Product
- Dr. King's SafeCare Rx Bed Wetting Prevention Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955001225, NDC 57955-0012-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 45
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)
- Lots: 102216B Exp. 08/2018
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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