The Recall Desk
SevereFDA (Drugs)·D-1122-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Glutathione Nasal Solution Due to Sterility Concerns

Montana Compounding Pharmacy is recalling specific lots of Glutathione Nasal Solution because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable or inhalation products are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the defect is structural to the product's safety.

Plain-English summary

Montana Compounding Pharmacy in Missoula, Montana, is recalling 10 vials of Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial. The specific lot affected is Lot 04102015:36@11, with an expiration date of 5/29/2015. The product was dispensed in Montana and North Dakota.

The recall was initiated due to a lack of assurance of sterility. This decision follows an FDA inspection during which objectionable conditions were observed. The agency has classified this as a Class II recall.

Consumers who have this specific product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
Manufacturer
Montana Compounding Pharmacy
Category
Drug — Compounded Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 04102015:36@11
  • expiry date: 5/29/2015

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 12 recalled by Montana Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Montana Compounding Pharmacy

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Same hazard · sterility

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