CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report
Glutathione Inhalation (PF), solution, 100mg/mL vial recalled
Montana Compounding Pharmacy is recalling Glutathione Inhalation (PF), solution, 100mg/mL vial, distributed in Montana, North Dakota. The recall was initiated on 15 May 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1121-2015
- FDA event ID
- 71275
- Recalling firm
- Montana Compounding Pharmacy, Missoula, MT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2015
- FDA classified
- 9 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 May 2015 | Recall initiated by company | |
| 9 Jun 2015 | Classified by FDA | +25 days |
| 17 Jun 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Where it was distributed
MT and ND
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Which lots are affected?
Lot 04102015:70@12; expiry date 5/28/2015.
Where was it sold?
MT and ND
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 71275More recalls from Montana Compounding Pharmacy
All 12Other Glutathione (pf recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glutathione Inhalation (PF), Nasal solution, 100 mg/mL vial recalled | Montana Compounding Pharmacy | Sterility | MT, ND |
| Drug | CLASS II | Glutathione PF, 60 mg/mL inhalation recalled by Specialty Medicine | Specialty Medicine Compounding Pharmacy | Sterility | MI |