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.
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: 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
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-assurance
- injectable-contamination
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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