FDA Recall D-0768-2019
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 SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955001621, NDC 57955-0193-2
Reason for recall
Microbial contamination
Recall record
- Recall number
D-0768-2019- 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