Recalls / Class I
Class ID-0555-2019
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 Lungs & Bronchial Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955505327, NDC 57955-5053-2
- Affected lot / code info
- Lot Numbers: 021718D Exp. 02/20; 091415H Exp. 09/18; 012616G Exp. 01/19; 033116A Exp. 03/19; 072916D Exp. 07/19; 091616A Exp. 0919; 121916C Exp. 12/19; 052517F Exp. 05/20; 112317C Exp. 11/19
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
- 26410 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-0555-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.