King Bio Recalls Acid Clenz Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Acid Clenz 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 per the rubric mandates a severity score of 5 (Critical) as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is voluntarily recalling 133 bottles of Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL). The recall is being conducted because the product is subject to microbial contamination.
The affected product is identified by NDC 57955-0127-2 and UPC 357955012726. The specific lots involved are 050216U (Expiration 05/19) and 072716C (Expiration 07/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers who have this product should stop using it and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012726, NDC 57955-0127-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Antacid
- Hazard
- Affected units
- 133
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: 050216U Exp. 05/19
- 072716C 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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