FDA Recall D-0960-2019
King Bio Inc. · Asheville, NC
Class I — life-threatening Terminated 1279 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Dr. King's Advanced Arnica Super Arnica, 59 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 800774305 UPC 357955181224
Reason for recall
Microbial contamination
Recall record
- Recall number
D-0960-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- U.S.A. Nationwide, Canada, and Australia.
- Recall initiated
- 2018-07-20
- Classified by FDA Center
- 2019-03-08
- FDA published
- 2019-03-20
- Terminated
- 2022-01-19
- Recalling firm
- King Bio Inc.
- Firm location
- Asheville, NC