Multi-event August 2018 FDA Recall Drug by Hellolife

This Multi-event Class I drug recall was voluntarily initiated by Hellolife on August 23, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile products; products contaminated with microoganisms, including but not limited to staphylococcus saprophyticus and burkholderia cepacia. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1203-2018 TERMINATED D-1200-2018 TERMINATED D-1202-2018 TERMINATED D-1201-2018 TERMINATED

Recall Number: D-1203-2018

Reason for Recall
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Initiated
08-23-2018
Reported
09-19-2018
Quantity
1,869 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80893
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hellolife
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: RE/030717E, exp 7/2019

Recall Number: D-1200-2018

Reason for Recall
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Initiated
08-23-2018
Reported
09-19-2018
Quantity
989 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80893
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hellolife
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2021
Product Description About Product Description
Full technical description of the product.
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02

Batch or Lot Expiration Information

Lot# Lot: CO/030717B, exp 7/2019

Recall Number: D-1202-2018

Reason for Recall
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Initiated
08-23-2018
Reported
09-19-2018
Quantity
370 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80893
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hellolife
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2021
Product Description About Product Description
Full technical description of the product.
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02

Batch or Lot Expiration Information

Lot# Lot: TV/030717F, exp 7/2019

Recall Number: D-1201-2018

Reason for Recall
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Initiated
08-23-2018
Reported
09-19-2018
Quantity
4,358 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80893
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hellolife
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2021
Product Description About Product Description
Full technical description of the product.
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02

Batch or Lot Expiration Information

Lot# Lot: NV/030717D, exp 7/2019