药品公告与召回美国 FDA 药品召回报告来源日期:2025-04-16
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60
编号:D-0337-2025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;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:2025-04-16
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
编号:D-0338-2025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;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:2025-04-16
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30
编号:D-0339-2025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;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:2025-04-16
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
编号:D-0340-2025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;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:2025-04-16
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
编号:D-0341-2025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;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:2025-04-16
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01
编号:D-0342-2025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;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:2025-04-16
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.
编号:D-0343-2025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;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:2025-04-16
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01
编号:D-0344-2025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;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:2025-04-16
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
编号:D-0345-2025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;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:2025-04-16
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
编号:D-0346-2025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;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:2025-04-16
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
编号:D-0347-2025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;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:2025-04-16
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
编号:D-0348-2025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;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:2025-04-16
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
编号:D-0349-2025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;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:2025-04-16
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
编号:D-0350-2025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;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:2025-04-16
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
编号:D-0351-2025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;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:2025-04-16
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01
编号:D-0352-2025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;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:2025-04-16
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
编号:D-0353-2025登记状态:公开召回企业 / 申办者:B. Braun Medical 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:2025-04-16
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)
编号:D-0354-2025登记状态:公开召回企业 / 申办者:Somerset Therapeutics Private Limited
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Media fill with bacterial contamination;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:2025-04-16
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
编号:D-0355-2025登记状态:公开召回企业 / 申办者:Somerset Therapeutics Private Limited
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Media fill with bacterial contamination;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:2025-04-16
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
编号:D-0356-2025登记状态:公开召回企业 / 申办者:Somerset Therapeutics Private Limited
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Media fill with bacterial contamination;安全性相关:是
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