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Week of Dec 1, 2025

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Dec 3, 2025approval269d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ERTUGLIFLOZIN →fda approvals ↗

Dec 3, 2025approval269d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: SEASONS BIOTECH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 3, 2025approval269d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

Dec 3, 2025approval269d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoFresenius Kabi USA, LLC recall (Cls I)Fresenius Kabi USA LLC

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). — Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall269d agoMedical Products Laboratories, Inc. recall (Cls II)Revalesio Corp

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 — Reason: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis — Status: Ongoing

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Dec 3, 2025recall269d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025device 510k269d agoBend IT Technologies, Ltd. — Bendit17 Microcatheter (510k cleared)TAT TECHNOLOGIES LTD

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

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Dec 3, 2025device 510k269d agoVoxel Ray Solutions, LLC — GentleBeam (GB1000) (510k cleared)

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

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Dec 3, 2025device 510k269d agoCoreline Soft Co., Ltd. — AVIEW Lung Nodule CAD (510k cleared)

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

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Dec 3, 2025device 510k269d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (510k cleared)

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

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Dec 3, 2025device 510k269d agoVitalograph , Ltd. — VitaloJAK Clinic (Model 7100) (510k cleared)

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

full page →fda device 510k ↗

Dec 3, 2025device 510k269d agoInsulet Corporation — Omnipod 5 algorithm (510k cleared)INSULET CORP

Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Dec 3, 2025device 510k269d agoHippoclinic — HippoMind (v1.0) (510k cleared)

Product code: OLT. Advisory committee: Neurology. Type: Traditional

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Dec 3, 2025device 510k269d agoYadu Medical (Henan) Co., Ltd. — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (510k cleared)

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

full page →fda device 510k ↗

Dec 3, 2025device 510k269d agoCovidien, LLC — Hugo RAS System (510k cleared)

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

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Dec 3, 2025device pma269d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

full page →fda device pma ↗

Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base 24970A (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Dec 3, 2025device pma269d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma269d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (PMA)

Product code: MTF. Advisory committee: IM. Decision: APPR

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Dec 3, 2025device pma269d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (PMA supplement)

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma269d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

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

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Dec 3, 2025device recall269d agoPhilips North America device recall (Cls II)

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

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Dec 3, 2025device recall269d agoPhilips Healthcare (Suzhou) Co., Ltd. device recall (Cls II)

Philips Incisive CT — Reason: Potential for incomplete scan due to unstable connection inside of floating sensor. — Status: Ongoing

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Dec 3, 2025device recall269d agoPhilips North America device recall (Cls II)

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

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Dec 3, 2025device recall269d agoCareFusion 303, Inc. device recall (Cls II)

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products. — Reason: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. — Status: Ongoing

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Dec 3, 2025device recall269d agoMedtronic Neuromodulation device recall (Cls II)

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900). — Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. — Status: Ongoing

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Dec 3, 2025device recall269d agoPhilips North America device recall (Cls II)

Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

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