Recalls / Class I
Class ID-0687-2019
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 SafeCare Rx Children's Ear Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955075721, NDC 57955-0758-2
- Affected lot / code info
- Lots: 032316B Exp. 03/19
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
- 45 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-0687-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.