King Bio Recalls Dr. King's SafeCare Rx Stye Free Eye Drops
King Bio Inc. is recalling 126 bottles of Dr. King's SafeCare Rx Stye Free eye drops 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 source text explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) because it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling 126 bottles of Dr. King's SafeCare Rx Stye Free eye drops, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0132-2 and UPC 357955012528.
The recall covers specific lots with the following expiration dates: 08/18 (Lot 083115B), 06/19 (Lot 061716A), 12/19 (Lot 120516B), and 01/20 (Lot 010418F). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should stop using the product and check their inventory for the listed lot numbers and expiration dates. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's SafeCare Rx Stye Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012528, NDC 57955-0132-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 126
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 (4)
- Lots: 083115B Exp. 08/18
- 061716A Exp. 06/19
- 120516B Exp. 12/19
- 010418F Exp. 01/20
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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