Levocarnitine 100mg/mL Solution Recall Due to Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to 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 of a sterile compounded injectable product where sterility assurance concerns have been identified by FDA inspection. Injectable products lacking sterility assurance present serious risk of infection or harm, meeting the rubric criterion for FDA Class II recalls with significant risk of adverse health outcomes.
Plain-English summary
Red Mountain Compounding Pharmacy, doing business as First Royal Care Co. LLC, is recalling Levocarnitine 100mg/mL MDV (multi-dose vial) solution (Rx only) due to lack of assurance of sterility. An FDA inspection identified concerns about the sterility assurance of this compounded injectable product.
The recalled product was distributed to approximately 494 patients and consumers who received prescriptions. Distribution was across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within their expiration dates are included in this recall.
Patients who have received this product should contact their healthcare provider or pharmacy for guidance. Levocarnitine is used to treat carnitine deficiency. Patients should not stop using the medication without consulting their healthcare provider, as doing so could affect their treatment.
Anyone with questions about this recall should contact the recalling pharmacy directly or consult the FDA's drug safety website.
The recalled product
- Product
- LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Compounded Injectable
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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