King Bio Recalls Allergy Homeopathic Product Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Allergies: Dairy due to potential microbial contamination that could pose a health risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which indicates a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. This classification mandates a severity score of at least 4.
Plain-English summary
King Bio Inc. has initiated a recall of Dr. King's SafeCare Rx Allergies: Dairy, a 2 fl. oz. (59 mL) homeopathic product. The recall covers 224 bottles distributed nationwide in the U.S., as well as to Canada and Australia. Affected lots include 073115B (expires 07/18), 062116B (expires 06/19), and 121216C (expires 12/19). The product was manufactured by King Bio Inc. in Asheville, NC.
The recall is being undertaken because the product may be contaminated with microorganisms. While the specific type of microbe is not detailed in the provided text, microbial contamination in a homeopathic remedy intended for allergy relief presents a potential safety concern for consumers who may ingest the product.
Consumers who possess this product should check the lot numbers on the label. If the product matches one of the recalled lots, they should stop using it immediately. Consumers are advised to contact King Bio Inc. or visit the FDA drug recalls website for further information and instructions on how to return or dispose of the product.
The recalled product
- Product
- Dr. King's SafeCare Rx Allergies: Dairy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955219828, NDC 57955-2198-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- Affected units
- 224
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: 073115B Exp. 07/18
- 062116B Exp. 06/19
- 121216C Exp. 12/19
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.
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