药品公告与召回美国 FDA 药品召回报告来源日期:2025-08-13
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
编号:D-0574-2025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:Presence of foreign substance: identified as aluminum.;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:2025-08-06
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
编号:D-0542-2025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:Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027;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:2025-08-06
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
编号:D-0543-2025登记状态:公开召回企业 / 申办者:FDC Limited
登记的停止原因(原文):FDA 召回:Defective Container: spike of the cap becomes 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:2025-08-06
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
编号:D-0544-2025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:CGMP Deviations; particulates identified during visual inspection;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:2025-08-06
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
编号:D-0545-2025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:CGMP Deviations; particulates identified during visual inspection;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:2025-08-06
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
编号:D-0546-2025登记状态:公开召回企业 / 申办者:Strides Pharma, Inc.
登记的停止原因(原文):FDA 召回:Failed Dissolution Specifications.;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:2025-08-06
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
编号:D-0547-2025登记状态:公开召回企业 / 申办者:Nostrum Laboratories, Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, qualit;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:2025-08-06
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
编号:D-0551-2025登记状态:公开召回企业 / 申办者:Hikma Pharmaceuticals USA Inc.
登记的停止原因(原文):FDA 召回:Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds;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:2025-07-30
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
编号:D-0535-2025登记状态:公开召回企业 / 申办者:Imprimis NJOF, LLC
登记的停止原因(原文):FDA 召回:Sub-Potent Drug: Subpotent assay results during stability testing.;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:2025-07-30
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
编号:D-0536-2025登记状态:公开召回企业 / 申办者:Imprimis NJOF, LLC
登记的停止原因(原文):FDA 召回:Sub-Potent Drug: Subpotent assay results during stability testing.;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:2025-07-30
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
编号:D-0537-2025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 retention sample testing at expiry.;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:2025-07-30
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
编号:D-0538-2025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:CGMP Deviations; potential temperature excursions due to transit delays;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:2025-07-30
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
编号:D-0539-2025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:CGMP Deviations; potential temperature excursions due to transit delays;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:2025-07-30
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
编号:D-0540-2025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:CGMP Deviations; potential temperature excursions due to transit delays;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:2025-07-30
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
编号:D-0541-2025登记状态:公开召回企业 / 申办者:Cipla USA, Inc.
登记的停止原因(原文):FDA 召回:Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.;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
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
编号:D-0516-2025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:Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).;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
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
编号:D-0517-2025登记状态:公开召回企业 / 申办者:Qualgen, LLC
登记的停止原因(原文):FDA 召回:Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.;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
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-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 16729-447-15
编号:D-0518-2025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, 25 mcg (0.025 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 16729-447-17
编号:D-0519-2025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, 50 mcg (0.05 mg), 90-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 16729-448-15
编号:D-0520-2025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 ↗