药品公告与召回美国 FDA 药品召回报告来源日期:2025-03-19
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
编号:D-0259-2025登记状态:公开召回企业 / 申办者:CareFusion 213, LLC
登记的停止原因(原文):FDA 召回:Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.;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:2025-03-19
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
编号:D-0260-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Alprostadil Container Description: Amber color bottle
编号:D-0261-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
编号:D-0262-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
编号:D-0263-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
编号:D-0264-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
编号:D-0265-2025登记状态:公开召回企业 / 申办者:Aspen Biopharma Labs Pvt., Ltd.
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:2025-03-19
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
编号:D-0266-2025登记状态:公开召回企业 / 申办者:Chattem Inc
登记的停止原因(原文):FDA 召回:CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.;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:2025-03-19
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
编号:D-0267-2025登记状态:公开召回企业 / 申办者:ICU Medical, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printe;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:2025-03-19
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
编号:D-0268-2025登记状态:公开召回企业 / 申办者:ICU Medical, Inc.
登记的停止原因(原文):FDA 召回:Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq;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:2025-03-19
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
编号:D-0269-2025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:2025-03-19
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
编号:D-0270-2025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:2025-03-19
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
编号:D-0271-2025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:2025-03-19
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
编号:D-0272-2025登记状态:公开召回企业 / 申办者:Central Admixture Pharmacy Services, Inc.
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter;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:2025-03-19
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
编号:D-0273-2025登记状态:公开召回企业 / 申办者:Denison Pharmaceuticals, LLC
登记的停止原因(原文):FDA 召回:Chemical Contamination: Presence of benzene.;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:2025-03-19
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
编号:D-0274-2025登记状态:公开召回企业 / 申办者:Sigan Industries Group Inc.
登记的停止原因(原文):FDA 召回:Chemical Contamination: Presence of benzene;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:2025-03-19
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
编号:D-0275-2025登记状态:公开召回企业 / 申办者:Johnson, S C and Son, Inc
登记的停止原因(原文):FDA 召回:Chemical Contamination;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:2025-03-19
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
编号:D-0276-2025登记状态:公开召回企业 / 申办者:Johnson, S C and Son, Inc
登记的停止原因(原文):FDA 召回:Chemical Contamination;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:2025-03-12
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
编号:D-0249-2025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;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:2025-03-12
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
编号:D-0250-2025登记状态:公开召回企业 / 申办者:Safecor Health, LLC
登记的停止原因(原文):FDA 召回:Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.;安全性相关:未知
查看官方原始记录 ↗