FDA Drug Recalls

Recalls / Class I

Class ID-0941-2019

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 #8 Allergy Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4208-2

Affected lot / code info
Lots: NR-031516F Exp. 03/19; NR-073015E Exp. 07/18; NR-010617F Exp. 01/20; NR-011216F Exp. 01/19; NR-021717E Exp. 02/20; NR-051116C Exp. 05/19; NR-060517B Exp. 06/20; NR-061616G Exp. 06/19; NR-080116C Exp. 08/19; NR-090115E Exp. 09/18; NR-090616G Exp. 09/19; NR-101916A Exp. 10/19; NR-120815J 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
23000 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-0941-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.