药品公告与召回美国 FDA 药品召回报告来源日期:2025-05-07
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
编号:D-0396-2025登记状态:公开召回企业 / 申办者:ACCORD HEALTHCARE, INC.
登记的停止原因(原文):FDA 召回:Subpotent;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:2025-05-07
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
编号:D-0397-2025登记状态:公开召回企业 / 申办者:ACCORD HEALTHCARE, INC.
登记的停止原因(原文):FDA 召回:Subpotent;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:2025-05-07
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
编号:D-0398-2025登记状态:公开召回企业 / 申办者:American Regent, Inc.
登记的停止原因(原文):FDA 召回:Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.;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:2025-05-07
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
编号:D-0399-2025登记状态:公开召回企业 / 申办者:American Regent, Inc.
登记的停止原因(原文):FDA 召回:Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.;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:2025-05-07
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
编号:D-0400-2025登记状态:公开召回企业 / 申办者:Mckesson Medical-Surgical Inc. Corporate Office
登记的停止原因(原文):FDA 召回:Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The;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:2025-05-07
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
编号:D-0401-2025登记状态:公开召回企业 / 申办者:Mckesson Medical-Surgical Inc. Corporate Office
登记的停止原因(原文):FDA 召回:Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The;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
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
编号:D-0367-2025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:Lack of assurance of sterility. Bacterial contamination detected in some media fill units;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
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
编号:D-0368-2025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:Lack of assurance of sterility. Bacterial contamination detected in some media fill units;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
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
编号:D-0369-2025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:Lack of assurance of sterility. Bacterial contamination detected in some media fill units;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
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
编号:D-0370-2025登记状态:公开召回企业 / 申办者:Denver Solutions, LLC DBA Leiters Health
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Leaking/damaged syringes.;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
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
编号:D-0371-2025登记状态:公开召回企业 / 申办者:Denver Solutions, LLC DBA Leiters Health
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Leaking/damaged syringes.;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
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
编号:D-0372-2025登记状态:公开召回企业 / 申办者:Denver Solutions, LLC DBA Leiters Health
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Leaking/damaged syringes.;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
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
编号:D-0373-2025登记状态:公开召回企业 / 申办者:Denver Solutions, LLC DBA Leiters Health
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Leaking/damaged syringes.;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
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
编号:D-0374-2025登记状态:公开召回企业 / 申办者:Denver Solutions, LLC DBA Leiters Health
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: Leaking/damaged syringes.;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
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
编号:D-0375-2025登记状态:公开召回企业 / 申办者:Apipharma
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
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
编号:D-0376-2025登记状态:公开召回企业 / 申办者:Apipharma
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
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
编号:D-0377-2025登记状态:公开召回企业 / 申办者:Lupin Pharmaceuticals Inc.
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.;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
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
编号:D-0378-2025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;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
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
编号:D-0379-2025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
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
编号:D-0380-2025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 ↗