FDAClass IIJune 17, 2015

Glutathione INHALATION recall: Sterility Concern

Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

Why was Glutathione INHALATION recalled?

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

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 04102015:70@12; expiry date 5/28/2015.

Product
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Recalling firm
Montana Compounding Pharmacy
Quantity
20/4 mL vials
Distribution
MT and ND
Recall date
June 17, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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