November 3, 2021DrugsFDA
Ultra Seal Corporation recalls ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablet
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister p
Hazard: Failed Moisture Limits
November 3, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)
Hazard: Failed Moisture Limits
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns