Ascorbic/Glutathione Eye Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.
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: This is an FDA Class II recall involving a sterile ophthalmic product where sterility assurance cannot be provided. Sterility defects in eye solutions pose serious infection risk, and the product is distributed to nearly 500 patients. Per the rubric, FDA Class II recalls are typically scored at 4 (Severe) when they involve products with inherent risk of serious harm.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution (Rx only) due to lack of assurance of sterility. An FDA inspection identified concerns regarding the manufacturer's ability to ensure the product's sterility.
The affected product was distributed to approximately 494 patients and consumers who received prescriptions in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently subject to recall remain within their expiration dates.
Patients currently using this eye solution should contact their healthcare provider or pharmacist for guidance. The risk associated with a non-sterile ophthalmic solution includes potential eye infection or other adverse effects if contamination is present.
The recalled product
- Product
- ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Ophthalmic / Eye Solution
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 (1)
- all lots within expiry
Distribution
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain 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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