Red Mountain Compounding Vitamin B Complex Injection Recall
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any confirmed illnesses, injuries, or hospitalizations; the hazard is a potential sterility defect. Per the rubric, FDA Class II recalls without reported hospitalization or injury are typically scored as High (3).
Plain-English summary
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling VIT B COMPLEX INJ SOLN (HP), a prescription injectable medication. The recall was initiated due to lack of assurance of sterility, which was raised during an FDA inspection.
Approximately 494 patients and consumers received prescriptions for this product. The affected patients are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots are still within their expiration date.
Consumers who have received this product should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should review patient records to identify patients who may have received this product and take appropriate action.
The recalled product
- Product
- VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-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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