FDAClass IIJuly 25, 2018

Glutathione 200mg/mL Injection w/Pres recall: Sterility Concern

Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Why was Glutathione 200mg/mL Injection w/Pres recalled?

Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

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?

Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018

Product
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Recalling firm
La Vita Compounding Pharmacy, LLC
Quantity
191 vials
Distribution
Product was distributed to patients via patient specific prescription only in CA.
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls