Recalls / Class I
Class ID-0899-2019
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
People's Best Arnica Gel Homeopathic Medicine Pain Relief, Net Wt. 2.6 oz (73 g), www.kingbio.com, UPC 357955320326, NDC 57955-3203-3
- Affected lot / code info
- Lots: 111617ZZ Exp. 11/19; 072016ZZ Exp. 07/18; 092316ZZ Exp. 09/18
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
- 1969 bottles
- 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-0899-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.