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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
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