FDA Recalls Dr. King's SafeCare Rx Acne Clear Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Acne Clear 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 FDA has classified this recall as Class I, which is the most serious type of recall and indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling 290 bottles of Dr. King's SafeCare Rx Acne Clear, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0041-2 and UPC 357955004127. The recall includes lots 091616K (Exp. 09/19) and 081617A (Exp. 08/19).
The product was distributed nationwide in the United States, as well as in Canada and Australia. The FDA has classified this recall as Class I, which is the most serious type of recall.
Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The recall was initiated by King Bio Inc. in response to the identified contamination.
The recalled product
- Product
- Dr. King's SafeCare Rx Acne Clear, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004127, NDC 57955-0041-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Acne Treatment
- Hazard
- Affected units
- 290
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: 091616K Exp. 09/19
- 081617A Exp. 08/19
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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