King Bio Recalls Dr. King's SafeCare Rx Heartache Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Heartache 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 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 153 bottles of Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL). The recall is being conducted due to microbial contamination. The affected product is identified by NDC 57955-2030-2 and UPC 357955203025.
The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. Specific lots affected include 082015A (Expiration 08/18) and 072516F (Expiration 07/19).
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and contact King Bio Inc. for further instructions or a refund.
The recalled product
- Product
- Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955203025, NDC 57955-2030-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical
- Hazard
- Affected units
- 153
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: 082015A Exp. 08/18
- 072516F Exp. 07/19
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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