Recalls / Class I
Class ID-0944-2019
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 #9 ER 911 Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4209-2
- Affected lot / code info
- Lots: NR-031816A Exp. 03/19; NR-073015F Exp. 07/18; NR-010617H Exp. 01/20; NR-011216C Exp. 01/19; NR-021717F Exp. 02/20; NR-050916A Exp. 10/19; NR-061716A Exp. 06/19; NR-080116B Exp. 08/19; NR-090115L Exp. 09/18; NR-090616H Exp. 09/19; NR-101916B Exp. 10/19; NR-120815H 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
- 38399 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-0944-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.