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

Recall #D-0040-2022 · 08/13/2021

Class II: Risk

Recall Details

Recall Number: D-0040-2022
Classification: Class II
Product Type: Drug
Recalling Firm: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Status: Terminated
Date Initiated: 08/13/2021
Location: Mesa, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

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

Product Description

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

Distribution Pattern

494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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

Class II: Risk 08/13/2021

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II: Risk 08/13/2021

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II: Risk 08/13/2021

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II: Risk 08/13/2021

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II: Risk 08/13/2021

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

View all recalls by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.