FDA Recall D-1203-2018
Hellolife · Grand Rapids, MI
Class I — life-threatening Terminated 888 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
Reason for recall
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Recall record
- Recall number
D-1203-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Switzerland Taiwan Turkey United Kingdom
- Recall initiated
- 2018-08-23
- Classified by FDA Center
- 2018-09-17
- FDA published
- 2018-09-19
- Terminated
- 2021-01-27
- Recalling firm
- Hellolife
- Firm location
- Grand Rapids, MI