Recalls / Class I
Class ID-0909-2019
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 Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC 357955404422, NDC 57955-4044-1
- Affected lot / code info
- Lots: 122216K Exp. 12/19; 120217P Exp. 12/19; 111117C Exp. 11/19; 083116C Exp. 08/19; 082316E Exp. 08/19; 072015A Exp. 07/18; 062716C Exp. 06/19; 062316B Exp. 06/19; 062218C Exp. 06/20; 052218C Exp. 05/20; 052118C Exp. 05/20; 051716J Exp. 05/19; 041816C Exp. 04/19; 030316A Exp. 03/19; 022317H Exp. 02/20; 111516H Exp. 11/19; 091815A Exp. 09/18; 062718C Exp. 06/20; 081815A Exp. 08/18
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
- 190189 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-0909-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.