FDA Recall D-0254-2019
Silver Star Brands · Oshkosh, WI
Class I — life-threatening Terminated 326 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
Reason for recall
Microbial Contamination of Non-Sterile Product
Recall record
- Recall number
D-0254-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide USA
- Recall initiated
- 2018-10-03
- Classified by FDA Center
- 2018-11-19
- FDA published
- 2018-11-14
- Terminated
- 2019-08-25
- Recalling firm
- Silver Star Brands
- Firm location
- Oshkosh, WI