药品公告与召回美国 FDA 药品召回报告来源日期:2025-07-09
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
编号:D-0500-2025登记状态:公开召回企业 / 申办者:Tailstorm Health INC
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.;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:2025-07-09
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
编号:D-0501-2025登记状态:公开召回企业 / 申办者:Tailstorm Health INC
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.;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:2025-07-09
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
编号:D-0502-2025登记状态:公开召回企业 / 申办者:Tailstorm Health INC
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.;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:2025-07-09
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
编号:D-0503-2025登记状态:公开召回企业 / 申办者:Tailstorm Health INC
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.;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:2025-07-09
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
编号:D-0504-2025登记状态:公开召回企业 / 申办者:Church & Dwight Inc
登记的停止原因(原文):FDA 召回:Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.;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:2025-07-09
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
编号:D-0505-2025登记状态:公开召回企业 / 申办者:Church & Dwight Inc
登记的停止原因(原文):FDA 召回:Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.;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:2025-07-09
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
编号:D-0506-2025登记状态:公开召回企业 / 申办者:Church & Dwight Inc
登记的停止原因(原文):FDA 召回:Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.;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:2025-07-09
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
编号:D-0507-2025登记状态:公开召回企业 / 申办者:The Harvard Drug Group LLC
登记的停止原因(原文):FDA 召回:Defective container; blister packaging inadequately sealed.;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:2025-07-09
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
编号:D-0508-2025登记状态:公开召回企业 / 申办者:The Harvard Drug Group LLC
登记的停止原因(原文):FDA 召回:Defective container; blister packaging inadequately sealed.;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:2025-07-09
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
编号:D-0510-2025登记状态:公开召回企业 / 申办者:Granules Pharmaceuticals Inc.
登记的停止原因(原文):FDA 召回:Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.;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:2025-07-09
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
编号:D-0526-2025登记状态:公开召回企业 / 申办者:Orient Pharma Co., Ltd. Yunlin Plant
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:2025-07-09
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
编号:D-0527-2025登记状态:公开召回企业 / 申办者:Orient Pharma Co., Ltd. Yunlin Plant
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:2025-07-09
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
编号:D-0528-2025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:Failed Impurity/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:2025-07-09
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
编号:D-0529-2025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:Failed Impurity/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:2025-07-09
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
编号:D-0569-2025登记状态:公开召回企业 / 申办者:Sandoz Inc
登记的停止原因(原文):FDA 召回:Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin;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:2025-07-09
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
编号:D-0570-2025登记状态:公开召回企业 / 申办者:Sandoz Inc
登记的停止原因(原文):FDA 召回:Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit;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
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
编号:D-0473-2025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:Presence of foreign tablets/capsules.;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
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0474-2025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
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0475-2025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
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
编号:D-0476-2025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 ↗