PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 17, 2015 Initiated: May 15, 2015 #D-1121-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
20/4 mL vials
Distribution
MT and ND
Location
Missoula, MT

Frequently Asked Questions

What product was recalled?
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.. Recalled by Montana Compounding Pharmacy. Units affected: 20/4 mL vials.
Why was this product recalled?
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Which agency issued this recall?
This recall was issued by the FDA Drug on June 17, 2015. Severity: Moderate. Recall number: D-1121-2015.