Abstract
- Firm Announcement Date:
- FDA Publish Date:
- Product Sort:
- Medication
- Cause for Announcement:
-
Recall Cause Description
On account of microbial contamination
- Firm Identify:
- Maison Terre
- Model Identify:
- Product Description:
Firm Announcement
North Little Rock, AR, Maison Terre is voluntarily recalling all a number of its Goldenseal Root Powder, bought from Starwest Botanicals, Sacramento, CA, and repackaged to the buyer stage attributable to microbial contamination. FDA laboratory evaluation of product samples discovered these merchandise to be contaminated with varied microorganisms together with: Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, amongst others.
Threat Assertion: Using contaminated product in in any other case wholesome sufferers may end up in infections necessitating antimicrobial and probably surgical therapy. In people with weak immune programs and infants, the usage of the product may end up in dying. Maison Terre has obtained a report of 1 toddler dying related to use of this product on the umbilical wire stump.
The product is a yellow coloured powder that is available in a transparent plastic bag, web weight of 1 oz.
The recalled Goldenseal Root Powder was distributed nationwide within the USA to clients who ordered via Amazon.com and bought between the dates of 01/25/2015 to 08/04/2020.
Maison Terre is notifying its clients by e-mail via Amazon.com. Prospects who’ve bought the Goldenseal Root Powder are urged to not devour or apply it. Prospects are urged to eliminate any unused portion. For these clients desirous to return the product for a refund, please contact Maison Terre for a return transport label.
Prospects with questions concerning this recall could contact Maison Terre at 501-888-9438, Mon-Fri, 10 am – 4 pm CST or at info@maisonterre.net. Shoppers ought to contact their doctor or healthcare supplier if they’ve skilled any issues which may be associated to taking or utilizing this drug product.
Opposed reactions or high quality issues skilled with the usage of this product could also be reported to the FDA’s MedWatch Opposed Occasion Reporting program both on-line, by common mail or by fax.
- Full and submit the report Online
- Common Mail or Fax: Download form or name 1- 800-332-1088 to request a reporting type, then full and return to the tackle on the pre-addressed type, or submit by fax to 1-800-FDA-0178
Maison Terre is conducting this recall with the information of the U.S. Meals and Drug Administration.
