药品公告与召回美国 FDA 药品召回报告来源日期:2025-07-02
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0477-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0478-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0479-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0480-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0481-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0482-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0483-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0484-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0485-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0486-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0487-2025登记状态:公开召回企业 / 申办者:Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
编号:D-0489-2025登记状态:公开召回企业 / 申办者:Pfizer Inc.
登记的停止原因(原文):FDA 召回:Discoloration; discolored solution from cracked 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:2025-07-02
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
编号:D-0490-2025登记状态:公开召回企业 / 申办者:Fresenius Medical Care Holdings, Inc.
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
编号:D-0491-2025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:Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.;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:2025-07-02
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
编号:D-0494-2025登记状态:公开召回企业 / 申办者:Apotex Corp.
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
编号:D-0495-2025登记状态:公开召回企业 / 申办者:Apotex Corp.
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
编号:D-0496-2025登记状态:公开召回企业 / 申办者:Apotex Corp.
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility;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:2025-07-02
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
编号:D-0531-2025登记状态:公开召回企业 / 申办者:Advanced Pharmaceutical Technology, Inc.
登记的停止原因(原文):FDA 召回:Marketed Without an Approved NDA/ANDA;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:2025-06-25
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
编号:D-0471-2025登记状态:公开召回企业 / 申办者:Aurobindo Pharma USA Inc
登记的停止原因(原文):FDA 召回:cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).;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:2025-06-25
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
编号:D-0472-2025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:Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.;安全性相关:未知
查看官方原始记录 ↗