FDA recall D-0064-2022
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · Class II · drug
Product
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Reason for recall
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Distribution
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-13
- Report date
- 2021-11-03
- Termination date
- 2023-04-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mesa, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2022