King Bio Recalls Upper GI Restoration Formula Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Upper GI Restoration Digestion Formula 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 per the rubric.
Plain-English summary
King Bio Inc. is recalling Dr. King's SafeCare Rx Upper GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL). The recall is being conducted due to microbial contamination.
The affected product is identified by NDC 57955-0325-2 and UPC 357955032120. The recall covers 756 bottles with the following lot numbers and expiration dates: 051716U (Exp. 05/19), 073115C (Exp. 07/18), 080216C (Exp. 08/19), and 120217N (Exp. 12/19).
The product was distributed nationwide in the United States, as well as in Canada and Australia. Consumers should check their inventory for these specific lot numbers and discontinue use if found.
The recalled product
- Product
- Dr. King's SafeCare Rx Upper GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 USA, UPC 357955032120, NDC 57955-0325-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 756
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: 051716U Exp. 05/19
- 073115C Exp. 07/18
- 080216C Exp. 08/19
- 120217N Exp. 12/19
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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