Mesa, AZ, United States
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls
2 recalls recorded since 2018, most recently on 13 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 13 August 2021
- Terminated
- 12 April 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0041-2022, D-0058-2022, D-0046-2022, D-0036-2022, D-0043-2022, D-0037-2022, D-0050-2022, D-0035-2022, D-0031-2022, D-0042-2022, D-0067-2022, D-0048-2022 and 28 more
- PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
- METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
- TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
- DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
- TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
- ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
- TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
- CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
- and 32 more product lines
Terminated Class II Drugs
- Recall started
- 12 August 2019
- Terminated
- 13 April 2023
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0229-2020, D-0245-2020, D-0208-2020, D-0235-2020, D-0250-2020, D-0254-2020, D-0240-2020, D-0210-2020, D-0281-2020, D-0272-2020, D-0276-2020, D-0220-2020 and 88 more
- S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
- S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
- S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx
- S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx
- S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx
- S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.
- S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX
- S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx
- and 92 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.