Ascorbic Acid Solution Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.
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: This is an FDA Class II recall. The hazard—lack of sterility assurance in a multi-dose injectable solution—creates a direct risk of serious infection and potential hospitalization, which meets the Severe category criteria for Class II recalls with significant injury/health risk potential, even in the absence of reported illnesses to date.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling all lots of Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution (Rx only) within their expiration dates. The recall was initiated following an FDA inspection that raised concerns about the sterility assurance of the product.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. Sterility assurance is critical for multi-dose injectable solutions to prevent contamination and infection risk.
Patients who have this product should consult their healthcare provider or pharmacist for guidance. The FDA is working with the recalling firm to ensure appropriate action is taken to protect public health.
The recalled product
- Product
- ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-assurance
- contamination-risk
- infection-risk
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
Distributed in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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