King Bio Recalls Dr. King's SafeCare Rx Immature Due to Microbial Contamination
King Bio Inc. is recalling 20 bottles of Dr. King's SafeCare Rx Immature 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 FDA classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) due to the reasonable probability of serious adverse health consequences.
Plain-English summary
King Bio Inc. is recalling 20 bottles of Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by Lot 060716J with an expiration date of 06/19. The NDC is 57955-2291-2 and the UPC is 357955229025.
The recall covers distribution in the U.S.A. Nationwide, Canada, and Australia. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Consumers should stop using the product and contact King Bio Inc. for instructions on return or disposal.
The recalled product
- Product
- Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955229025, NDC 57955-2291-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical / Ophthalmic
- Hazard
- Affected units
- 20
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 (1)
- Lot: 060716J Exp. 06/19
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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