Recalls / Class I
Class ID-0252-2019
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
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
- Affected lot / code info
- Lot K051818A
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Silver Star Brands
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2155 S Oakwood Rd, Oshkosh, Wisconsin 54904-6359
Distribution
- Quantity
- 95 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-10-03
- FDA classified
- 2018-11-19
- Posted by FDA
- 2018-11-14
- Terminated
- 2019-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0252-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.