FDAClass IIJune 12, 2013

Glutathione 200 mg/mL Injectable recall: Sterility Concern

Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Why was Glutathione 200 mg/mL Injectable recalled?

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots

Product
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Recalling firm
THE COMPOUNDING SHOP, INC.
Quantity
7 vials of 50mL each
Distribution
Florida, California, Minnesota, and Maine
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls