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FDA Drug Recalls·· 19 天前精选AI 评分83

Centric Compounding 因内毒素水平升高召回谷胱甘肽、Myer's Cocktail 和 Tri-Immune Boost 注射剂瓶

Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels

AI 导读

Centric Compounding 于 9 月 9 日宣布自愿召回 6 个批次的 Glutathione 200 mg/mL、Myer's Cocktail 和 Tri-Immune Boost 注射剂瓶至消费者层面。

推荐理由

公告列出谷胱甘肽、Myer's Cocktail和Tri-Immune Boost共6个批次的产品名称、批号与失效日期,以及全国分发方式和已报告不良反应例数。

正文 · 原文

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
September 11, 2026
FDA Publish Date:
September 13, 2026
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Elevated Endotoxin level

Company Name:
Centric Compounding LLC
Brand Name:

Brand Name(s)

Centric Compounding

Product Description:

Product Description

Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial


Company Announcement

FOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials to the consumer level. The products have been found to be compounded with a Glutathione API containing elevated endotoxin levels.

Risk Statement: There is reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death. Centric Compounding has received 9 reports of fever, chills, chest pain, nausea/vomiting, headache, and/or malaise.

The products are used to support immunity, fatigue, and general wellness and are packaged in 30mL multidose vials. The affected Glutathione, Myer’s Cocktail, and Tri-Immune Boost lots include the following lot numbers and expiration dates:

Product Name

Lot #

Beyond Use Date

Glutathione 200mg/ml 30mL vial

062326:B

8/7/26

Glutathione 200mg/ml 30mL vial

070826:A

8/22/26

Glutathione 200mg/ml 30mL vial

072726:D

9/25/26

Myer's Cocktail 30mL vial

070226:D

8/16/26

Myer's Cocktail 30mL vial

072126:A

9/4/26

Tri-Immune Boost 30mL vial

071626:B

8/30/26

These products were distributed Nationwide to patients via home delivery and delivery to prescribers.

Centric Compounding is notifying its distributors and customers by email and is arranging for replacement of all recalled products. Consumers that have Glutathione, Myer’s Cocktail, and Tri-Immune Boost which is being recalled should stop using and discard any affected vials.

Consumers with questions regarding this recall can contact Centric Compounding by phone at 833-777-6664 or [email protected] on Monday through Friday from 9am to 5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

来源:FDA Drug Recalls · fda.gov