Greenwich Rx 因内毒素水平升高自愿全国召回复方谷胱甘肽注射液
Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels
Greenwich Rx 于 2026 年 10 月 1 日宣布在全国范围自愿召回特定批次的复方谷胱甘肽注射液至消费者层面，原因是内毒素水平可能升高。召回涉及 200 mg/mL、10mL 多剂量瓶共 10 个批号，产品于 2026 年 6 月 26 日至 9 月 21 日发往全国患者。该 503A 配制药房称已收到两例患者在静脉注射并非为静脉给药配制的谷胱甘肽产品后接受急诊治疗的报告。
材料列出召回批号、失效日期与分销时间范围，便于核对涉及批次并了解内毒素水平可能升高的风险描述。
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.
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Summary
- Company Announcement Date:
- October 01, 2026
- FDA Publish Date:
- October 01, 2026
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Potential elevated endotoxin levels
- Company Name:
- Greenwich Rx
- Brand Name:
-
Brand Name(s)
Greewich
- Product Description:
-
Product Description
Glutathione Injection
Company Announcement
IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential 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. To date, Greenwich Rx has received two reports involving patients who received emergency department care following intravenous (IV) administration of a glutathione product that was not formulated for IV use.
Glutathione is a naturally occurring antioxidant that helps protect cells from oxidative stress. The voluntary recall affects the following lots of compounded glutathione 200 mg/mL dispensed in 10mL multidose vials and intended for subcutaneous injection:
Product | Strength | Package Size | Lot Number | Beyond Use Date |
|---|---|---|---|---|
Glutathione | 200 mg/mL | 10mL | 0060-062426-1 | 10/02/2026 |
0060-062726-1 | 10/05/2026 | |||
0060-070926-1 | 10/17/2026 | |||
0060-071426-1 | 10/22/2026 | |||
0060-071426-2 | 10/22/2026 | |||
0060-072026-1 | 10/28/2026 | |||
0060-072726-1 | 11/04/2026 | |||
0060-072926-1 | 11/06/2026 | |||
0060-073126-1 | 11/08/2026 | |||
0060-080426-1 | 11/12/2026 |
The glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026. Refer to the photo of the product label below for the location of lot number and beyond use date.
Greenwich Rx is notifying customers of this voluntary recall by mail. Customers who received glutathione from one of the recalled lots should stop using the product and follow the disposal instructions provided in the recall notification. Patients who believe they have experienced a health issue that may be related to the product should contact their healthcare provider.
Customers can direct questions regarding this recall to Sedgwick at (866) 552-4916 or [email protected] Monday through Friday between 8:00 AM to 5:00 PM Eastern Time.
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
来源：FDA Drug Recalls · fda.gov