FDAClass IISeptember 18, 2013

RL Glutathione 100 mg/mL recall: Sterility Concern

RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627

Why was RL Glutathione 100 mg/mL recalled?

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

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# 130710@27, Use By: 1/6/2014

Product
RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627
Recalling firm
Wellness Pharmacy, Inc.
Quantity
34 Vials
Distribution
Nationwide and Puerto Rico
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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