Montana Compounding Recalls Glutathione Inhalation Due to Sterility Risks
Montana Compounding Pharmacy recalls specific lots of Glutathione Inhalation solution due to lack of sterility assurance. Check your vial details.
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Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
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What happened, in plain English
Montana Compounding Pharmacy is recalling Glutathione INHALATION (PF) solution because it lacks assurance of sterility. This issue was identified during an FDA inspection that also noted objectionable conditions. The recall affects specific lots dispensed in Montana and North Dakota. Read more at govinfonow.com/recall/44695-montana-compounding-pharmacy-recalls-glutathione-inhalation-pf-solution-100mg-ml.
Source Summary by GovInfoNow · govinfonow.com/recall/44695-montana-compounding-pharmacy-recalls-glutathione-inhalation-pf-solution-100mg-ml · Updated October 12, 2026 · FDA enforcement record: FDA #D-1121-2015
Cite this page
“Montana Compounding Recalls Glutathione Inhalation Due to Sterility Risks.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44695-montana-compounding-pharmacy-recalls-glutathione-inhalation-pf-solution-100mg-ml. Based on FDA recall #D-1121-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1121-2015%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, meaning it may contain harmful microorganisms. Using a non-sterile solution for inhalation can lead to serious infections or other health complications.
Who’s affected
Patients who received this prescription medication from Montana Compounding Pharmacy in Missoula, MT, specifically those with vials distributed in Montana and North Dakota.
How to tell if you have this one
Look for Glutathione INHALATION (PF) solution, 100mg/mL, in 4 mL vials. Check the lot number for '04102015:70@12' and an expiry date of '5/28/2015'. The product was dispensed by Montana Compounding Pharmacy.
- Brand
Montana Compounding Pharmacy- Category
Drug
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
MT and ND
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1117-2015 | Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 03252015:61@6, expiry date: 7/23/2015 | 1/5mL vial |
| D-1118-2015 | Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 04022015:93@10, expiry date: 7/31/2015; | 1/5 mL vial |
| D-1119-2015 | Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 04202015:49@1, Expiry date: 5/20/2015; Lot 04272015:06@6, Expiry date: 6/2/2015; Lot 04282015:16@13, Expiry date: 6/12/2015; Lot 05062015:56@3, Expiry date: 5/24/2015; | 259/0.05 mL Syringes |
| D-1120-2015 | Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.; Lot 04102015:18@15, expiry date: 7/3/2015 | 1/5mL vial |
| D-1121-2015 | Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.; Lot 04102015:70@12; expiry date 5/28/2015. | 20/4 mL vials |
| D-1122-2015 | Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT; Lot 04102015:36@11, expiry date: 5/29/2015 | 10/3 mL vials |
| D-1123-2015 | Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 02062015:06@3, expiry date: 5/17/2015; Lot 02272015:93@1, expiry date: 6/30/2015; Lot 03252015:92@7, expiry date: 6/30/2015; Lot 04162015:63@7, expiry date: 6/30/2015. | 20/1 mL vials |
| D-1124-2015 | Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 04162015:77@4, Expiry date: 6/8/2015 | 1/1 mL. vial |
| D-1125-2015 | Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.; Lot 02112015:78@15, expiry dates: 6/1/2015; Lot 04062015:03@9, expiry dates: 6/8/2015 | 32/2 mL vials |
| D-1126-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 03112015:17@5; Expiry date: 6/1/2015; Lot 04042015:61@2; Expiry date: 6/3/2015; Lot 05022015:11@2; Expiry date: 6/16/2015; | 25/5 mL. vials |
| D-1127-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 04082015:49@7; expiry date: 6/18/2015; Lot 04222015:25@8; expiry date: 7/3/2015. | 2/5 mL vials |
| D-1128-2015 | Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT; Lot 04062015:18@1. Expiry date: 8/1/2015 | 1/5 mL vial |
What to do — step by step
Stop using the medication
Do not use the recalled Glutathione Inhalation solution vials due to sterility concerns.
Contact your pharmacy
Reach out to Montana Compounding Pharmacy or your healthcare provider for further instructions on disposal or replacement.
Where it went and when
Where it was distributed
Distributed in Montana and North Dakota.
FDA distribution: “MT and ND” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Montana, North Dakota.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1121-2015 (May 15, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1121-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.