Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
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.
VIT B COMPLEX INJ SOLN (HP), 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
BENZALKONIUM CHLORIDE 0.013% SOLUTION, 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
Calcium Chloride, 100 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
METHYLCOBALAMIN 5000MCG/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
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
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 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
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Moisture Limits
CALCIUM GLUCONATE 10% INJ (PF), 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
MIC 25/50/50MG/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
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), 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
VIT B COMPLEX INJ SOLN (HP), 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
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, 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
PROGESTERONE 100MG/ML MDV OIL INJECTION, 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.
LEVOCARNITINE 100MG/ML MDV SOLN, 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
MIC/B12A/B6 15/50/100 5MG/50MG/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