药品公告与召回美国 FDA 药品召回报告来源日期:2025-05-14
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
编号:D-0404-2025登记状态:公开召回企业 / 申办者:BRS Analytical Services, LLC
登记的停止原因(原文):FDA 召回:cGMP deviations and 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:2025-05-14
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
编号:D-0405-2025登记状态:公开召回企业 / 申办者:BRS Analytical Services, LLC
登记的停止原因(原文):FDA 召回:cGMP deviations and 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:2025-05-14
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.
编号:D-0406-2025登记状态:公开召回企业 / 申办者:BRS Analytical Services, LLC
登记的停止原因(原文):FDA 召回:cGMP deviations and 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:2025-05-14
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
编号:D-0407-2025登记状态:公开召回企业 / 申办者:BRS Analytical Services, LLC
登记的停止原因(原文):FDA 召回:cGMP deviations and 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:2025-05-14
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
编号:D-0408-2025登记状态:公开召回企业 / 申办者:BRS Analytical Services, LLC
登记的停止原因(原文):FDA 召回:cGMP deviations and 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:2025-05-14
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
编号:D-0409-2025登记状态:公开召回企业 / 申办者:Apollo Care, LLC
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:2025-05-14
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
编号:D-0410-2025登记状态:公开召回企业 / 申办者:Siddha Flower Essences, 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:2025-05-14
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
编号:D-0411-2025登记状态:公开召回企业 / 申办者:RemedyRePack Inc.
登记的停止原因(原文):FDA 召回:CGMP Deviations - products manufactured in a shared facility with Ezetimibe 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:2025-05-14
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
编号:D-0412-2025登记状态:公开召回企业 / 申办者:BSO LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: Glass particles were found in pellet vials.;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:2025-05-14
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
编号:D-0413-2025登记状态:公开召回企业 / 申办者:BSO LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: Glass particles were found in pellet vials.;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:2025-05-14
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
编号:D-0414-2025登记状态:公开召回企业 / 申办者:BSO LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: Glass particles were found in pellet vials.;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:2025-05-14
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01
编号:D-0415-2025登记状态:公开召回企业 / 申办者:BSO LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: Glass particles were found in pellet vials.;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:2025-05-14
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
编号:D-0416-2025登记状态:公开召回企业 / 申办者:BSO LLC
登记的停止原因(原文):FDA 召回:Presence of Particulate Matter: Glass particles were found in pellet vials.;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:2025-05-07
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
编号:D-0389-2025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:Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.;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:2025-05-07
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
编号:D-0390-2025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:Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.;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:2025-05-07
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
编号:D-0391-2025登记状态:公开召回企业 / 申办者:Preferred Pharmaceuticals, Inc.
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:2025-05-07
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).
编号:D-0392-2025登记状态:公开召回企业 / 申办者:Nubratori, Inc
登记的停止原因(原文):FDA 召回:Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are la;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:2025-05-07
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
编号:D-0393-2025登记状态:公开召回企业 / 申办者:Cardinal Health Inc.
登记的停止原因(原文):FDA 召回:Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. Mo;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:2025-05-07
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, 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-0394-2025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;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:2025-05-07
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
编号:D-0395-2025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;安全性相关:是
查看官方原始记录 ↗