King Bio Recalls Children's Ear Relief Due to Microbial Contamination
King Bio Inc. is recalling 45 bottles of Dr. King's SafeCare Rx Children's Ear Relief 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 recall is classified as FDA Class I, which per the rubric corresponds to a Critical severity score of 5.
Plain-English summary
King Bio Inc. is recalling 45 bottles of Dr. King's SafeCare Rx Children's Ear Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL). The recall was initiated due to microbial contamination.
The affected product is identified by Lot 032316B with an expiration date of 03/19. The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The recall is classified as FDA 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 Children's Ear Relief 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 357955075721, NDC 57955-0758-2
- 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: 032316B Exp. 03/19
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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