TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Lupin Pharmaceuticals
Class I - Dangerous
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.