Recalls / Class I
Class ID-0598-2019
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 Natural Medicine Homeopathic Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503927, NDC 57955-5839-2
- Affected lot / code info
- Lots: 021016E Exp. 02/19; 060118C Exp. 06/20; 060518A Exp. 06/20; 071318G Exp. 07/20; 080717A Exp. 08/19; 081315N Exp. 08/18; 111516J Exp. 11/19; 122017A Exp. 12/2019; 122915D Exp. 12/18
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
- 18449 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-0598-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.