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, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
编号:D-0236-2025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, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
编号:D-0237-2025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, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
编号:D-0238-2025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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
编号:D-0239-2025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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
编号:D-0240-2025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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
编号:D-0241-2025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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
编号:D-0242-2025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, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
编号:D-0243-2025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, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
编号:D-0244-2025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
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
编号:D-0245-2025登记状态:公开召回企业 / 申办者:Alvogen, Inc
登记的停止原因(原文):FDA 召回:Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.;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:2025-02-19
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
编号:D-0224-2025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:Out of Specification for Dissolution;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:2025-02-12
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
编号:D-0214-2025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:2025-02-12
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
编号:D-0215-2025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 Carvedilol I impurity (NNCI-I) 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:2025-02-12
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
编号:D-0216-2025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 Carvedilol I impurity (NNCI-I) 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:2025-02-12
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
编号:D-0217-2025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 Carvedilol Impurity-1 (NNC 1), above the FDA recommended 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:2025-02-12
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
编号:D-0218-2025登记状态:公开召回企业 / 申办者:Teva Pharmaceuticals USA, Inc
登记的停止原因(原文):FDA 召回:Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit;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:2025-02-12
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
编号:D-0219-2025登记状态:公开召回企业 / 申办者:SKY PACKAGING
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:2025-02-12
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
编号:D-0220-2025登记状态:公开召回企业 / 申办者:SKY PACKAGING
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:2025-02-12
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
编号:D-0221-2025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 Dissolution 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:2025-02-12
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
编号:D-0222-2025登记状态:公开召回企业 / 申办者:PAI Holdings, LLC. dba Pharmaceutical Associates Inc
登记的停止原因(原文):FDA 召回:Superpotent; sodium benzoate preservative;安全性相关:是
查看官方原始记录 ↗