Recalls / Class II
Class IID-0064-2022
Product
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
- Affected lot / code info
- all lots within expiry
Why it was recalled
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recalling firm
- Firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 6828 E Brown Rd Ste 101, N/A, Mesa, Arizona 85207-3761
Distribution
- Quantity
- N/A
- Distribution pattern
- 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Timeline
- Recall initiated
- 2021-08-13
- FDA classified
- 2021-10-26
- Posted by FDA
- 2021-11-03
- Terminated
- 2023-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0064-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.