Recalls / Class I
Class ID-0946-2019
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
NET Remedies #7 Flora Plus Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2
- Affected lot / code info
- Lots: NR-090115K Exp. 09/18; NR-031516G Exp. 03/19; NR-011216E Exp. 10/19; NR-021717D Exp. 02/20; NR-042717C Exp. 04/20; NR-061616F Exp. 06/19; NR-090616F Exp. 09/19; NR-101416G Exp. 10/19; NR-120815M Exp. 12/18; NR-020118H Exp. 02/20; NR-020618J Exp. 02/20; NR-081017H Exp. 08/19; NR-101117E Exp. 10/19
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
- 9888 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-0946-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.