Multi-event August 2021 FDA Recall Drug by First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy on August 13, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT. and the recall is currently terminated.
Reported Recall Events
D-0041-2022 D-0042-2022 D-0047-2022 D-0044-2022 D-0032-2022 D-0064-2022 D-0043-2022 D-0031-2022 D-0057-2022 D-0036-2022 D-0034-2022 D-0065-2022 D-0045-2022 D-0028-2022 D-0052-2022 D-0046-2022 D-0035-2022 D-0039-2022 D-0062-2022 D-0060-2022 D-0058-2022 D-0048-2022 D-0059-2022 D-0029-2022 D-0061-2022 D-0040-2022 D-0067-2022 D-0038-2022 D-0050-2022 D-0051-2022 D-0049-2022 D-0033-2022 D-0037-2022 D-0066-2022 D-0054-2022 D-0030-2022 D-0055-2022 D-0053-2022 D-0056-2022 D-0063-2022
Recall Number: D-0041-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0042-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0047-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0044-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0032-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0064-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0043-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0031-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0057-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0036-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0034-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0065-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0045-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0028-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0052-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0046-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0035-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0039-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0062-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0060-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0058-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0048-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0059-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0029-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0061-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0040-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0067-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0038-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0050-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0051-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0049-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0033-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0037-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0066-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0054-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0030-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0055-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0053-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0056-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
Recall Number: D-0063-2022
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
08-13-2021
11-03-2021
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Batch or Lot Expiration Information
Lot# all lots within expiry
