Methylcobalamin Injectable: Sterility Assurance Deficiency
Red Mountain Compounding Pharmacy is recalling methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.
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 product with a deficiency in sterility assurance. Sterile injectables that lack proper assurance of sterility pose a direct risk of serious infection and harm to patients, even without reported illnesses to date.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling all lots of methylcobalamin 1000 mcg/mL injectable (multi-dose vial, prescription only) due to lack of assurance of sterility identified during an FDA inspection.
The recall affects 494 patients and consumers who received prescriptions for this product across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Non-sterile injectable medications can pose serious health risks including infection and sepsis. Consumers who have received this product should contact their healthcare provider or pharmacist immediately for guidance on their next steps and to discuss whether they need any medical evaluation.
The recalled product
- Product
- METHYLCOBALAMIN 1000MCG/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-deficiency
- infection-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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