Ascorbic Acid Injectable Solution Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL Solution for Injection due to lack of assured sterility identified during an FDA inspection. The affected product was distributed to approximately 494 patients in seven 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 an injectable pharmaceutical product. Lack of sterility assurance in injectable medications poses a significant risk of serious infections and poses substantial risk of harm even though no specific illnesses have been reported in the source text, meeting the Severe classification criteria.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Ascorbic Acid (Non-Corn) 500mg/mL Solution for Injection, prescription-only product, due to concerns about sterility assurance raised during an FDA inspection.
The recall encompasses all lots of the product that remain within their expiration dates. Approximately 494 patients received prescriptions for this product, with distribution documented in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Consumers who have received this product and have questions should contact their healthcare provider or pharmacy. Patients should not discontinue use of ascorbic acid therapy without consulting their healthcare provider, who can determine an appropriate alternative.
The recalled product
- Product
- ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
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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