Recalls / Class I
Class ID-0699-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955400035, NDC 57955-4000-3
- Affected lot / code info
- Lots: 052616 Exp. 05/19; 073118ZZ Exp. 07/21; 040117ZZ Exp. 06/19; 122717ZZ Exp. 12/20; 040417ZZ Exp. 04/20; 091617ZZ Exp. 09/20
Why it was recalled
Microbial contamination
Recalling firm
- Firm
- King Bio Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3 Westside Dr, N/A, Asheville, North Carolina 28806-2846
Distribution
- Quantity
- 17527 tubes
- Distribution pattern
- U.S.A. Nationwide, Canada, and Australia.
Timeline
- Recall initiated
- 2018-07-20
- FDA classified
- 2019-03-08
- Posted by FDA
- 2019-03-20
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0699-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.