药品公告与召回美国 FDA 药品召回报告来源日期:2025-04-30
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15
编号:D-0381-2025登记状态:公开召回企业 / 申办者:Pharmadel, 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:2025-04-30
Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02
编号:D-0382-2025登记状态:公开召回企业 / 申办者:Pharmadel, 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:2025-04-30
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
编号:D-0383-2025登记状态:公开召回企业 / 申办者:Pharmadel, 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:2025-04-30
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
编号:D-0384-2025登记状态:公开召回企业 / 申办者:Pharmadel, 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:2025-04-30
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
编号:D-0385-2025登记状态:公开召回企业 / 申办者:OurPharma LLC
登记的停止原因(原文):FDA 召回:Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..;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:2025-04-30
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
编号:D-0386-2025登记状态:公开召回企业 / 申办者:Medisca Inc.
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:2025-04-30
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
编号:D-0387-2025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 Nitrosamine Drug Substance Related Impurity above the proposed 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:2025-04-30
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
编号:D-0388-2025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 Nitrosamine Drug Substance Related Impurity above the proposed 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:2025-04-23
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
编号:D-0362-2025登记状态:公开召回企业 / 申办者:Chattem Inc
登记的停止原因(原文):FDA 召回:CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended 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:2025-04-23
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
编号:D-0363-2025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: complaints of crystals not redissolving into solution after warming and shaking the vials.;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:2025-04-23
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
编号:D-0364-2025登记状态:公开召回企业 / 申办者:Direct Rx
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:2025-04-23
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
编号:D-0365-2025登记状态:公开召回企业 / 申办者:Dr. Reddy's Laboratories, Inc.
登记的停止原因(原文):FDA 召回:LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the produc;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:2025-04-23
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
编号:D-0366-2025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:CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine 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:2025-04-16
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
编号:D-0310-2025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:Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.;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
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
编号:D-0311-2025登记状态:公开召回企业 / 申办者:SUN PHARMACEUTICAL INDUSTRIES INC
登记的停止原因(原文):FDA 召回:Cross 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
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
编号:D-0312-2025登记状态:公开召回企业 / 申办者:SUN PHARMACEUTICAL INDUSTRIES INC
登记的停止原因(原文):FDA 召回:Cross 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
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1
编号:D-0313-2025登记状态:公开召回企业 / 申办者:ASEGUA THERAPEUTICS LLC
登记的停止原因(原文):FDA 召回:Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.;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
Fenofibrate Capsules 67 mg, USP, 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# 68462-580-01
编号:D-0314-2025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 225mg, 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# 68462-408-60
编号:D-0315-2025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 325mg, 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# 68462-409-60
编号:D-0316-2025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
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