Recalls / Class I
Class ID-0959-2019
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 Acute Pain Relief Cooling Topical, 89 mL (topical cream), Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80074489 UPC 357955181439
- Affected lot / code info
- Lot: 020417ZZ Exp. 02/20
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
- 192 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-0959-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.