Glutathione 200mg/mL MDV Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.
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 sterility assurance defect in a compounded injectable drug product. While no hospitalizations or illnesses are explicitly reported in the source text, the lack of sterility assurance in an injectable product intended for injection poses a significant risk of harm and justifies a Class II designation and Severe severity rating.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Glutathione 200mg/mL MDV, a prescription injectable product, due to lack of assurance of sterility.
During an FDA inspection, sterility assurance concerns were raised regarding this compounded product. The recall affects all lots within their expiry period.
Approximately 494 patients who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. Consumers who have received this product should contact their healthcare provider or pharmacist for guidance.
This is a Class II recall issued by the FDA under recall number D-0038-2022.
The recalled product
- Product
- GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Compounded Injection
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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