Drug Recalls

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0034-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0045-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0059-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0056-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0050-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0036-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0060-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0067-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0033-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0051-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0044-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0066-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0040-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0058-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0028-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0062-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0047-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0041-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0038-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0054-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0049-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0039-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0031-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0055-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0046-2022 November 3, 2021 Mesa, AZ

FDA Enforcement Report