September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Com
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habr
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habr
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
Pharmcore Inc. recalls Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Hazard: Lack of assurance of sterility.
September 5, 2018DrugsFDA
RemedyRepack Inc. recalls Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD,
Hazard: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufact
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufa
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufa
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufact
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 7
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulask
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.