King Bio Recalls Restless Leg Syndrome Product Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Restless Leg Syndrome due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
King Bio Inc. is recalling 143 bottles of Dr. King's SafeCare Rx Restless Leg Syndrome, 2 fl. oz. (59 mL). The recall is due to microbial contamination.
The affected product is identified by NDC 57955-0445-2 and UPC 357955044529. Specific lots include 051716X (Exp. 05/19) and 101116A (Exp. 10/19). The product was distributed nationwide in the U.S.A., 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 recalled product
- Product
- Dr. King's SafeCare Rx Restless Leg Syndrome, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955044529, NDC 57955-0445-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical / OTC
- Hazard
- Affected units
- 143
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: 051716X Exp. 05/19
- 101116A Exp. 10/19
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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