FDA Recalls Dr. King's Ear Relief Formula Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Ear Relief Formula 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 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
King Bio Inc. is recalling 185 bottles of Dr. King's SafeCare Rx Ear Relief Formula, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0154-2 and UPC 357955015727.
The affected lots are 062215F (Expiration 06/18) and 091316A (Expiration 09/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should check their inventory for these specific lot numbers and expiration dates. If you have this product, you should stop using it and contact the manufacturer or a healthcare provider for further instructions.
The recalled product
- Product
- Dr. King's SafeCare Rx Ear Relief Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955015727, NDC 57955-0154-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Ophthalmic/Ear Drops
- Hazard
- Affected units
- 185
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: 062215F Exp. 06/18
- 091316A Exp. 09/19
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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