药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-22
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
编号:D-0203-2025登记状态:公开召回企业 / 申办者:Viatris Inc
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-22
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
编号:D-0204-2025登记状态:公开召回企业 / 申办者:Viatris Inc
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
编号:D-0177-2025登记状态:公开召回企业 / 申办者:Buy-Herbal
登记的停止原因(原文):FDA 召回:Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
编号:D-0178-2025登记状态:公开召回企业 / 申办者:Endo USA, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
编号:D-0179-2025登记状态:公开召回企业 / 申办者:Endo USA, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
编号:D-0180-2025登记状态:公开召回企业 / 申办者:Endo USA, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
编号:D-0181-2025登记状态:公开召回企业 / 申办者:Endo USA, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
编号:D-0182-2025登记状态:公开召回企业 / 申办者:FDC Limited
登记的停止原因(原文):FDA 召回:Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
编号:D-0183-2025登记状态:公开召回企业 / 申办者:West-Ward Columbus Inc
登记的停止原因(原文):FDA 召回:Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
编号:D-0184-2025登记状态:公开召回企业 / 申办者:Amerisource Health Services LLC
登记的停止原因(原文):FDA 召回:Presence of Foreign Tablets/Capsules;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
编号:D-0185-2025登记状态:公开召回企业 / 申办者:Eugia US LLC
登记的停止原因(原文):FDA 召回:CGMP Deviations;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
编号:D-0186-2025登记状态:公开召回企业 / 申办者:Eugia US LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
编号:D-0187-2025登记状态:公开召回企业 / 申办者:Granules Pharmaceuticals Inc.
登记的停止原因(原文):FDA 召回:Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
编号:D-0188-2025登记状态:公开召回企业 / 申办者:Rising Pharma Holding, Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
编号:D-0189-2025登记状态:公开召回企业 / 申办者:Rising Pharma Holding, Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
编号:D-0190-2025登记状态:公开召回企业 / 申办者:Rising Pharma Holding, Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
编号:D-0191-2025登记状态:公开召回企业 / 申办者:Jubilant Draximage Inc., dba Jubilant Radiopharma
登记的停止原因(原文):FDA 召回:Failed Stability Specifications;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-15
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
编号:D-0192-2025登记状态:公开召回企业 / 申办者:Granules Pharmaceuticals Inc.
登记的停止原因(原文):FDA 召回:Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.;安全性相关:未知
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-08
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
编号:D-0167-2025登记状态:公开召回企业 / 申办者:Lupin Pharmaceuticals Inc.
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.;安全性相关:是
查看官方原始记录 ↗药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-08
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
编号:D-0168-2025登记状态:公开召回企业 / 申办者:AvKARE
登记的停止原因(原文):FDA 召回:Failed Dissolution Specifications;安全性相关:未知
查看官方原始记录 ↗