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Recall Information


MediNatura Inc. is voluntarily recalling some production lots of 4 of its OTC aqueous-based products within expiry, due to possible microbial contamination. Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention. To date, MediNatura has not received any reports of illness or injury. 

 

The production lots of these products were made by a third-party supplier who no longer manufactures for MediNatura.  Several months ago, we transferred the manufacture of our nasal sprays and throat sprays to another facility that has a history of favorable FDA inspections.  The cough syrup is discontinued.

 

MediNatura is notifying its direct customers by email, fax, and/or letter to make arrangements for the return of recalled products.  Distributors and retailers that have recalled product should immediately discontinue selling or distributing and contact MediNatura at recall@medinatura.com to arrange for a return. Consumers with questions regarding this recall can contact MediNatura at 1-800-920-9203 Tuesday - Friday 8:30 a.m. - 3:30 p.m., Mountain Standard Time, or email recall@medinatura.com.

 

Consumers are encouraged to return the recalled product to the place of purchase or complete and return the recall form and send it back to MediNatura per the instructions on the form.

 

Consumers should discontinue use immediately Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

 

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's

MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

・ Online: Complete and submit the report online at  www.fda.gov/medwatch/report.htm

・ Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

We apologize for any inconvenience this recall has caused.  Your safety is our primary concern and we felt this is the best course of action to take.

 

List of products being recalled is below. The lot number is located on the bottom pane of the carton and also on the bottle label.

 

Product

NDC

UPC

Lot

Expiration

clearlife_nasal_spray

CLEARLIFE NASAL SPRAY
20ml bottle   

62795-4002-9

78764710188 7

110716

11/7/2018

021417

2/14/2019

041917

4/19/2019

111617

11/16/2020

ReBoost Nasal Spray Decongestion

REBOOST NASAL SPRAY
20ml bottle   

62795-4001-9

78764710186 3

100616

10/6/2018

021517

2/15/2019

042017

4/19/2019

100517

10/19/2019

ReBoost Sore Throat Spray Natural Homeopathic

REBOOST THROAT SPRAY
20ml bottle             

 

62795-4003-9

78764730096 9

080317

8/3/2019

100417

10/4/2019

120717

12/7/2019

011018

1/10/2020

022018

2/20/2020

ReBoost Cough Syrup Honey

REBOOST COUGH SYRUP 
125ml bottle   

62795-3001-1

78764770404 0

101716

10/17/2018

011017

1/10/2019

021617

2/16/2019

092117

9/21/2019

120617

12/6/2020

022718

2/27/2021

Contact Us

Phone:
844-633-4628

Email Inquiries:
info@medinatura.com

Mailing Address:
MediNatura
1055 Westlakes Drive, Suite 300
Berwyn, PA 19312

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