July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, S
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spok
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spo
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane,
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokan
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 992
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Phar
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Ph
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, Firs
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associ
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Phar
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
First Pharma Associates LLC dba Riverpoint Pharmacy recalls Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharm
Hazard: Lack of Assurance of Sterility.
July 17, 2019DrugsFDA
American Health Packaging recalls Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manuf
Hazard: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
July 17, 2019DrugsFDA
MAJOR PHARMACEUTICALS recalls Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major P
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
July 17, 2019DrugsFDA
Golden State Medical Supply Inc. recalls Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Golden State Medical Supply Inc. recalls Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Golden State Medical Supply Inc. recalls Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Golden State Medical Supply Inc. recalls Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Phar
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharm
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.