药品公告与召回美国 FDA 药品召回报告来源日期:2025-03-12
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
编号:D-0251-2025登记状态:公开召回企业 / 申办者:Safecor Health, LLC
登记的停止原因(原文):FDA 召回:Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.;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:2025-03-12
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
编号:D-0252-2025登记状态:公开召回企业 / 申办者:Safecor Health, LLC
登记的停止原因(原文):FDA 召回:Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.;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:2025-03-12
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
编号:D-0253-2025登记状态:公开召回企业 / 申办者:Safecor Health, LLC
登记的停止原因(原文):FDA 召回:Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.;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:2025-03-12
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
编号:D-0254-2025登记状态:公开召回企业 / 申办者:Safecor Health, LLC
登记的停止原因(原文):FDA 召回:Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.;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:2025-03-12
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
编号:D-0255-2025登记状态:公开召回企业 / 申办者:Zydus Pharmaceuticals (USA) Inc
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications;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:2025-03-12
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
编号:D-0256-2025登记状态:公开召回企业 / 申办者:Zydus Pharmaceuticals (USA) Inc
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications;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:2025-03-05
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
编号:D-0246-2025登记状态:公开召回企业 / 申办者:Padagis US LLC
登记的停止原因(原文):FDA 召回:Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.;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:2025-03-05
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
编号:D-0247-2025登记状态:公开召回企业 / 申办者:Wuxi Medical lnstrument Factory Co., Ltd.
登记的停止原因(原文):FDA 召回:Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.;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:2025-03-05
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
编号:D-0248-2025登记状态:公开召回企业 / 申办者:Turbare Manufacturing
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: due to a quality control process deviation;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:2025-02-26
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
编号:D-0225-2025登记状态:公开召回企业 / 申办者:Fagron Compounding Services
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-02-26
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
编号:D-0226-2025登记状态:公开召回企业 / 申办者:The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
登记的停止原因(原文):FDA 召回:Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.;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:2025-02-26
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
编号:D-0227-2025登记状态:公开召回企业 / 申办者:The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
登记的停止原因(原文):FDA 召回:Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.;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:2025-02-26
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
编号:D-0228-2025登记状态:公开召回企业 / 申办者:The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
登记的停止原因(原文):FDA 召回:Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.;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:2025-02-26
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
编号:D-0229-2025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:Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%);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:2025-02-26
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
编号:D-0230-2025登记状态:公开召回企业 / 申办者:Provepharm Inc.
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter.;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:2025-02-26
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
编号:D-0231-2025登记状态:公开召回企业 / 申办者:Glenmark Pharmaceuticals Inc., USA
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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:2025-02-26
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
编号:D-0232-2025登记状态:公开召回企业 / 申办者:Glenmark Pharmaceuticals Inc., USA
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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:2025-02-26
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
编号:D-0233-2025登记状态:公开召回企业 / 申办者:Glenmark Pharmaceuticals Inc., USA
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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:2025-02-26
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
编号:D-0234-2025登记状态:公开召回企业 / 申办者:Glenmark Pharmaceuticals Inc., USA
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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:2025-02-26
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
编号:D-0235-2025登记状态:公开召回企业 / 申办者:Glenmark Pharmaceuticals Inc., USA
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.;安全性相关:是
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