药品公告与召回美国 FDA 药品召回报告来源日期:2025-07-23
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
编号:D-0521-2025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 Drug: Assay below the approved 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:2025-07-23
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
编号:D-0522-2025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 Drug: Assay below the approved 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:2025-07-23
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
编号:D-0523-2025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 Drug: Assay below the approved 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:2025-07-23
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17
编号:D-0524-2025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 Drug: Assay below the approved 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:2025-07-23
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
编号:D-0525-2025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:Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole 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:2025-07-23
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
编号:D-0530-2025登记状态:公开召回企业 / 申办者:Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
登记的停止原因(原文):FDA 召回:Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.;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:2025-07-23
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
编号:D-0532-2025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:Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazan;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:2025-07-23
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
编号:D-0533-2025登记状态:公开召回企业 / 申办者:Ascend Laboratories, LLC
登记的停止原因(原文):FDA 召回:CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable 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:2025-07-23
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
编号:D-0534-2025登记状态:公开召回企业 / 申办者:Ascend Laboratories, LLC
登记的停止原因(原文):FDA 召回:CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable 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:2025-07-23
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
编号:D-0548-2025登记状态:公开召回企业 / 申办者:A.P. Deauville, 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:2025-07-23
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
编号:D-0549-2025登记状态:公开召回企业 / 申办者:A.P. Deauville, 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:2025-07-23
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
编号:D-0550-2025登记状态:公开召回企业 / 申办者:A.P. Deauville, 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:2025-07-16
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
编号:D-0509-2025登记状态:公开召回企业 / 申办者:Macleods Pharmaceuticals Ltd
登记的停止原因(原文):FDA 召回:Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed 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:2025-07-16
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
编号:D-0511-2025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 N-nitroso-duloxetine impurity above FDA 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:2025-07-16
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.
编号:D-0512-2025登记状态:公开召回企业 / 申办者:KABANA SKIN CARE
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:2025-07-16
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
编号:D-0513-2025登记状态:公开召回企业 / 申办者:KABANA SKIN CARE
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:2025-07-16
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
编号:D-0514-2025登记状态:公开召回企业 / 申办者:KABANA SKIN CARE
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:2025-07-16
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
编号:D-0515-2025登记状态:公开召回企业 / 申办者:KABANA SKIN CARE
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:2025-07-09
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
编号:D-0498-2025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
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
编号:D-0499-2025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 ↗