D-0028-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- August 13, 2021
- Termination Date
- April 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Reason for Recall
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Distribution Pattern
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Code Information
all lots within expiry