FDAFDA · Food and drugs·Recall number D-0057-2022
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Published November 3, 2021 · Recall initiated: August 13, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Distributor
- 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
- Lot
- all lots within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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