FDA Drug Recalls

Recalls / Class I

Class ID-0921-2019

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 #5 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia

Affected lot / code info
Lots: AUS-011117E Exp. 01/20; AUS-011916E Exp. 01/19; AUS-030816E Exp. 03/19; AUS-050516E Exp. 05/19; AUS-101116A 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
2200 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-0921-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class I recall: drug · FDA Drug Recalls