FDAClass IIJuly 20, 2016

L-glutathione 100mg/ml recall: Sterility Concern

L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY

Why was L-glutathione 100mg/ml recalled?

Lack of Assurance of Sterility

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 #: 160222-28, BUD: 05/22/16; Lot #: 160302-63, BUD: 05/31/16

Product
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
Recalling firm
Medaus, Inc.
Quantity
5000 mL in Vials
Distribution
U.S. Nationwide, Japan, and New Zealand.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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