药品公告与召回美国 FDA 药品召回报告来源日期:2025-01-08
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
编号:D-0169-2025登记状态:公开召回企业 / 申办者:SOMERSET THERAPEUTICS LLC
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:2025-01-08
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
编号:D-0170-2025登记状态:公开召回企业 / 申办者:GNMart LLC
登记的停止原因(原文):FDA 召回:Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.;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
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
编号:D-0171-2025登记状态:公开召回企业 / 申办者:VIONA PHARMACEUTICALS INC
登记的停止原因(原文):FDA 召回:Crystallization;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
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
编号:D-0172-2025登记状态:公开召回企业 / 申办者:VIONA PHARMACEUTICALS INC
登记的停止原因(原文):FDA 召回:Crystallization;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
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
编号:D-0173-2025登记状态:公开召回企业 / 申办者:Hikma Injectables USA Inc
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.;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
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
编号:D-0174-2025登记状态:公开召回企业 / 申办者:Hikma Injectables USA Inc
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.;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
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
编号:D-0175-2025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:LABELING: LABEL MIX-UP;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
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
编号:D-0176-2025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:LABELING: LABEL MIX-UP;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:2025-01-01
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
编号:D-0155-2025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:CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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:2025-01-01
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
编号:D-0156-2025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:CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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:2025-01-01
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
编号:D-0157-2025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:CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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:2025-01-01
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
编号:D-0158-2025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:CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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:2025-01-01
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
编号:D-0159-2025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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current 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:2025-01-01
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
编号:D-0160-2025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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current 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:2025-01-01
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
编号:D-0161-2025登记状态:公开召回企业 / 申办者:Breckenridge Pharmaceutical, Inc
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA 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:2025-01-01
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
编号:D-0162-2025登记状态:公开召回企业 / 申办者:Breckenridge Pharmaceutical, Inc
登记的停止原因(原文):FDA 召回:CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA 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:2025-01-01
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
编号:D-0163-2025登记状态:公开召回企业 / 申办者:PD-Rx Pharmaceuticals, Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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:2025-01-01
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
编号:D-0164-2025登记状态:公开召回企业 / 申办者:Curium US, LLC
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product;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:2025-01-01
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
编号:D-0165-2025登记状态:公开召回企业 / 申办者:RemedyRepack 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:2025-01-01
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
编号:D-0166-2025登记状态:公开召回企业 / 申办者:MXBBB
登记的停止原因(原文):FDA 召回:cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirmi;安全性相关:是
查看官方原始记录 ↗