Glutathione Inhalation Solution Recalled for Lack of Sterility Assurance
First Pharma Associates is recalling specific vials of Glutathione 100 mg/mL Inhalation Solution due to a lack of assurance of 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for an inhalation solution, which poses a significant risk of serious injury or infection.
Plain-English summary
First Pharma Associates LLC dba Riverpoint Pharmacy is recalling 45 mL vials of Glutathione 100 mg/mL Inhalation Solution (PF). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by Lot # 06172019@3 and has an expiration date of 08/18/2019. The product was distributed only in Idaho and Washington. It is a prescription-only medication.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
- Category
- Drug — Inhalation Solution
- 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 #: 06172019@3
- Exp. 08/18/2019
Distribution
Part of a larger recall action
This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint 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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