Methylcobalamin Injectable Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling methylcobalamin 10,000 MCG/ML multi-dose vials after FDA inspection identified sterility assurance concerns.
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 product. Loss of sterility assurance in a multi-dose injectable poses a significant risk of serious infection or harm to patients; injectable products carry inherent risks when sterility cannot be assured, meeting the criteria for a Severe classification.
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling methylcobalamin 10,000 MCG/ML multi-dose injectable solution for prescription use due to lack of assurance of sterility. The FDA inspection raised concerns about the manufacturer's ability to ensure the product's sterility.
Approximately 494 patients and consumers received prescriptions for this product. The affected product was distributed across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots remain within their stated expiry dates.
Patients who have received this medication should consult their healthcare provider about appropriate follow-up and whether continued use is safe. Healthcare providers and patients should report any adverse effects to the FDA's MedWatch program.
The recalled product
- Product
- METHYLCOBALAMIN 10,000MCG/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
- contamination-risk
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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