Methylcobalamin Injection Recalled for Sterility Assurance Deficiency
Red Mountain Compounding Pharmacy is recalling Methylcobalamin 5000 mcg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
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 involving a sterile injectable drug. Lack of sterility assurance for an injectable medication poses significant risk of serious infection or sepsis if contaminated product was administered. Although no illnesses or hospitalizations are reported in the source text, the hazard type (compromised sterility of an injection) and the Class II classification warrant a Severe rating.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Methylcobalamin 5000 mcg/mL multi-dose vial injectable medication. The recall was initiated after FDA inspection raised concerns about sterility assurance, meaning there is insufficient evidence that the product is free of bacterial, fungal, and other microbial contamination.
The affected product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All recalled lots are within their expiration dates.
Patients who have received this medication should consult with their healthcare provider or pharmacist regarding whether they have received the recalled product and whether any action is needed. Healthcare providers may contact the manufacturer directly with questions about the recall.
The recalled product
- Product
- METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance
- injection-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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