Calendar

Week of Dec 8, 2025

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall253d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10. — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Status: Ongoing

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Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall253d agoTeva Pharmaceuticals USA, Inc recall (Cls III)Terns Pharmaceuticals, Inc.

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17. — Reason: Defective Container - A defect in the side-seal which allows leakage of product. — Status: Ongoing

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Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoCipla Limited recall (Cls II)Cipla Ltd

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96 — Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index — Status: Ongoing

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Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall253d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05. — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025device 510k253d agoJeil Medical Corporation — ARIX Femur Nail System (510k cleared)

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

full page →fda device 510k ↗

Dec 10, 2025device 510k253d agoPromisemed Hangzhou Meditech Co., Ltd. — Verisafe Safety Retractable Insulin Syringes (510k cleared)Shanghai Jiao Tong University

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

full page →fda device 510k ↗

Dec 10, 2025device 510k253d agoHuxley Medical — SANSA HSAT (510k cleared)

Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Dec 10, 2025device 510k253d agoBrainspace, Inc. — Intellidrop (510k cleared)

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

full page →fda device 510k ↗

Dec 10, 2025device pma253d agoBoston Scientific Corp — Vercise Genus Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NHL. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Dec 10, 2025device pma253d agoBiotronik, Inc. — Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie (PMA supplement)

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

full page →fda device pma ↗

Dec 10, 2025device pma253d agoSTAAR Surgical Company — Visian® Toric Implantable Collamer® Lens (TICL) (PMA supplement)STAAR SURGICAL CO

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

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Dec 10, 2025device pma253d agoCompanion Spine France Sas — DIAM Spinal Stabilization System (PMA)

Product code: NQO. Advisory committee: OR. Decision: APPR

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Dec 10, 2025device pma253d agoMedtronic Minimed, Inc. — MiniMed 670G system MiniMed 770G system MiniMed 780G system (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

full page →fda device pma ↗

Dec 10, 2025device pma253d agoMedtronic Minimed, Inc. — Simplera Sync Sensor; Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

full page →fda device pma ↗

Dec 10, 2025device pma253d agoBiotronik, Inc. — Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR (PMA supplement)

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

full page →fda device pma ↗

Dec 10, 2025device pma253d agoBoston Scientific Corp — WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Dec 10, 2025device recall253d agoElekta, Inc. device recall (Cls II)

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) — Reason: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice — Status: Ongoing

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Dec 10, 2025device recall253d agoREPLIGEN CORPORATION device recall (Cls II)REPLIGEN CORP

MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496 — Reason: Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle. — Status: Ongoing

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Dec 10, 2025device recall253d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

SMV DSI, System, Tomography, Computed, Emission — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. — Status: Ongoing

full page →fda device recalls ↗

Dec 10, 2025device recall253d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

SMV BodyTrack, System, Tomography, Computed, Emission — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. — Status: Ongoing

full page →fda device recalls ↗

Dec 10, 2025device recall253d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

SMV DSX New Line, System, Tomography, Computed, Emission — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. — Status: Ongoing

full page →fda device recalls ↗

Dec 10, 2025device recall253d agoMazor Robotics Ltd device recall (Cls II)

Mazor X robotic guidance system REF: TPL0059 — Reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery. — Status: Ongoing

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Dec 10, 2025device recall253d agoGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING device recall (Cls II)

MAXXUS, System, Tomography, Computed, Emission — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. — Status: Ongoing

full page →fda device recalls ↗

Dec 11, 2025approval252d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval252d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval252d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalPERRIGO Co plc

Sponsor: LNK INTL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval252d agoDEFERIPRONE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval252d agoBLUJEPA (GEPOTIDACIN MESYLATE) — FDA approvalgepotidacin mesylate

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →gepotidacin mesylate →fda approvals ↗

Dec 11, 2025approval252d agoCABERGOLINE — FDA approvalCABERGOLINE

Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL

full page →CABERGOLINE →fda approvals ↗

Dec 11, 2025approval252d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 11, 2025approval252d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

full page →enzalutamide →fda approvals ↗

Dec 11, 2025approval252d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Dec 11, 2025approval252d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

Sponsor: BIOCRYST. Form: PELLETS. Route: ORAL

full page →berotralstat hydrochloride →fda approvals ↗

Dec 11, 2025approval252d agoNOREPINEPHRINE BITARTRATE — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: MSN. Form: INJECTABLE. Route: INJECTION

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

Dec 11, 2025approval252d agoUPLIZNA (INEBILIZUMAB-CDON) — FDA approvalHorizon Therapeutics USA Inc

Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 11, 2025approval252d agoDAYBUE STIX (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: FOR SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

Dec 11, 2025approval252d agoLOPINAVIR AND RITONAVIR (LOPINAVIR) — FDA approvalLOPINAVIR AND RITONAVIR

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →LOPINAVIR AND RITONAVIR →fda approvals ↗

Dec 11, 2025device 510k252d agoA Plus Biotechnology Co., Ltd. — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (510k cleared)Avistone Biotechnology Co Ltd

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

full page →fda device 510k ↗

Dec 11, 2025device 510k252d agoKLS-Martin L.P. — KLS Martin Pure Pectus System (510k cleared)

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

full page →fda device 510k ↗

Dec 11, 2025device 510k252d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

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Week of Dec 8, 2025