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Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall311d agoApotex Corp. recall (Cls II)Apotex Corp

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing

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Oct 8, 2025recall311d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing

full page →fda recalls ↗

Oct 8, 2025recall311d agoApotex Corp. recall (Cls II)Apotex Corp

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing

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Oct 8, 2025recall311d agoAmerisource Health Services LLC recall (Cls II)Teva Pharmaceuticals USA Inc

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) — Reason: Failed Dissolution Specifications. — Status: Ongoing

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Oct 8, 2025device 510k311d agoRoche Diagnostics — Elecsys Phospho-Tau (181P) Plasma (510k cleared)Dawn Sea Therapeutics

Product code: SET. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗

Oct 8, 2025device 510k311d agoBellamia Technologies, Inc. — The Botticelli (Model: Athena) (510k cleared)BETA Technologies, Inc.

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Oct 8, 2025device 510k311d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Saf-T-Intima Subcutaneous Catheter System (510k cleared)

Product code: FOZ. Advisory committee: General Hospital. Type: Traditional

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Oct 8, 2025device 510k311d agoExtremity Medical, LLC — MetaFore Small Screw System (510k cleared)

Product code: HWC. Advisory committee: Orthopedic. Type: Traditional

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Oct 8, 2025device 510k311d agoSerpex Medical, Inc. — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (510k cleared)

Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Special

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Oct 8, 2025device 510k311d agoAbiomed, Inc. — 14Fr Low Profile Introducer Kit (510k cleared)Abion Inc

Product code: DYB. Advisory committee: Cardiovascular. Type: Special

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Oct 8, 2025device 510k311d agoIntegra LifeSciences Corporation — CUSA® Clarity Ultrasonic Surgical Aspirator System (510k cleared)INTEGRA LIFESCIENCES HOLDINGS CORP

Product code: LFL. Advisory committee: Unknown. Type: Traditional

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Oct 8, 2025device 510k311d agoElekta Solutions AB — ProKnow DS (510k cleared)

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

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Oct 8, 2025device 510k311d agoClinical Innovations, LLC — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) (510k cleared)

Product code: HDB. Advisory committee: Obstetrics/Gynecology. Type: Traditional

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Oct 8, 2025device 510k311d agoGenoray Co., Ltd. — GT300; GT300-C (510k cleared)

Product code: OAS. Advisory committee: Radiology. Type: Traditional

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Oct 8, 2025device pma311d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Oct 8, 2025device pma311d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

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Oct 8, 2025device pma311d agoRxsight, Inc. — Light Adjustable Lens and Light Delivery Device (PMA supplement)RxSight, Inc.

Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR

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Oct 8, 2025device pma311d agoMedtronic, Inc. — PulseSelect Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

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Oct 8, 2025device pma311d agoNovocure, GmbH — Optune Lua® (PMA supplement)NovoCure Ltd

Supplement type: 30-Day Notice. Product code: SDA. Advisory committee: AN. Decision: OK30

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Oct 8, 2025device pma311d agoTorax Medical — LINX Reflux Management System (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: LEI. Advisory committee: GU. Decision: APPR

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Oct 8, 2025device recall311d agoOlympus Corporation of the Americas device recall (Cls II)

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. Component: ShockPulse Lithotripsy System — Reason: The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use. — Status: Ongoing

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Oct 8, 2025device recall311d agoCellavision AB device recall (Cls II)

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component. — Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. — Status: Ongoing

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Oct 8, 2025device recall311d agoSterilmed, Inc. device recall (Cls II)

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A — Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. — Status: Ongoing

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Oct 8, 2025device recall311d agoSterilmed, Inc. device recall (Cls II)

Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A — Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. — Status: Ongoing

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Oct 9, 2025approval310d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

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Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 9, 2025approval310d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 9, 2025approval310d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Oct 9, 2025approval310d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →alirocumab →fda approvals ↗

Oct 9, 2025approval310d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval310d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

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Oct 9, 2025approval310d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Oct 9, 2025approval310d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →TRAVOPROST →fda approvals ↗

Oct 9, 2025approval310d agoIXIFI (INFLIXIMAB-QBTX) — FDA approvalIXIFI

Sponsor: PFIZER INC. Form: INJECTABLE. Route: INJECTION

full page →IXIFI →fda approvals ↗

Oct 9, 2025approval310d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 9, 2025approval310d agoPEMETREXED DISODIUM — FDA approvalLilly USA LLC

Sponsor: RELIANCE LIFE. Form: POWDER. Route: INTRAVENOUS

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Oct 9, 2025approval310d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗

Oct 9, 2025approval310d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗

Oct 9, 2025approval310d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL

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Week of Oct 6, 2025