Montana Compounding Pharmacy Recalls Glutathione Inhalation Solution Due to Sterility Concerns
Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about 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, which corresponds to a Severe severity score under the rubric for significant potential harm without confirmed fatalities.
Plain-English summary
Montana Compounding Pharmacy in Missoula, Montana, is recalling 20 vials of Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only. The recall was initiated because objectionable conditions were observed during a U.S. Food and Drug Administration (FDA) inspection, which resulted in a lack of assurance of sterility for the product.
The affected product is identified by Lot 04102015:70@12 and has an expiry date of 5/28/2015. The product was distributed in Montana and North Dakota. This is a prescription-only medication.
Consumers and healthcare providers who have this specific lot of Glutathione Inhalation solution should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Glutathione INHALATION (PF), solution, 100mg/mL, 4 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 04102015:70@12
- expiry date 5/28/2015.
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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