Levocarnitine Injectable Solution Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling levocarnitine 100 mg/mL injectable solution (all lots within expiry) due to FDA inspection findings that raised sterility assurance concerns. Approximately 494 patients in seven states received prescriptions.
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: The FDA classified this as a Class II recall. The hazard involves a sterility assurance deficiency in an injectable pharmaceutical product, which presents a significant potential for patient harm through infection or other serious complications. Although no illnesses or injuries are reported in the source, a sterility failure in an injected drug product meets the Severe threshold under the rubric for Class II recalls with potential for significant harm.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling levocarnitine 100 mg/mL multidose vial solution (prescription-only) in all unexpired lots. The recall was initiated following an FDA inspection that raised concerns about the lack of assurance of sterility for this injectable product.
Approximately 494 patients and consumers received prescriptions for this product. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Consumers who have received this medication should consult with their healthcare provider or pharmacist before using it. Prescribers and pharmacists should review dispensing records and contact affected patients if necessary. Questions can be directed to the recalling firm, First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy.
The recalled product
- Product
- LEVOCARNITINE 100MG/ML MDV SOLN, 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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