Calendar

Week of Sep 8, 2025

Sep 10, 2025recall337d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

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Sep 10, 2025recall337d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

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Sep 10, 2025recall337d agoDermaRite Industries, LLC recall (Cls I)

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

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Sep 10, 2025recall337d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

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Sep 10, 2025recall337d agoDermaRite Industries, LLC recall (Cls I)

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

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Sep 10, 2025recall337d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

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Sep 10, 2025recall337d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

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Sep 10, 2025recall337d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 — Reason: Presence of Particulate Matter — Status: Ongoing

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Sep 10, 2025recall337d agoIMMUNOCORE, LLC recall (Cls II)Immunocore Holdings plc

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 — Reason: Subpotent Drug — Status: Ongoing

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Sep 10, 2025recall337d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

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Sep 10, 2025device 510k337d agoMerit Medical System, Inc. — Surfacer Inside-Out Access Catheter System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

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Sep 10, 2025device 510k337d agoMr Surgical Solutions, LLC — OptiVu Shoulder (510k cleared)

Product code: SBF. Advisory committee: Neurology. Type: Special

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Sep 10, 2025device 510k337d agoFisher & Paykel Healthcare, Ltd. — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (510k cleared)

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

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Sep 10, 2025device 510k337d agoBeckman Coulter, Inc. — iQ200 Series (510k cleared)

Product code: LKM. Advisory committee: Hematology. Type: Special

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Sep 10, 2025device 510k337d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Sep 10, 2025device 510k337d agoVizionfocus, Inc. — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

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Sep 10, 2025device 510k337d agoAngiowave Imaging, Inc. — AngioWaveNet (510k cleared)

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

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Sep 10, 2025device 510k337d agoPollogen, Ltd. — OptiLUV Device (510k cleared)

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

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Sep 10, 2025device 510k337d agoTimpel S.A. — Enlight 2100 (TPL-E2103-0) (510k cleared)TIM S.A.

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

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Sep 10, 2025device pma337d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge (PMA supplement)JOHNSON & JOHNSON

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

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Sep 10, 2025device pma337d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR

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Sep 10, 2025device pma337d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Sep 10, 2025device pma337d agoABBOTT MEDICAL — CardioMEMSTM HF System (PMA supplement)

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

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Sep 10, 2025device pma337d agoBeaver Visitec International, Inc. — FINEVISION HP Trifocal IOLs (PMA)

Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma337d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

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

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Sep 10, 2025device pma337d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

Supplement type: Panel Track. Product code: MAQ. Advisory committee: MI. Decision: APPR

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Sep 10, 2025device pma337d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (PMA supplement)JOHNSON & JOHNSON

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

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Sep 10, 2025device pma337d agoBiosense Webster, Inc. — VARIPULSE Catheter (PMA supplement)

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

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Sep 10, 2025device pma337d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multifocal 3-Piece IOL (PMA supplement)JOHNSON & JOHNSON

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

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Sep 10, 2025device pma337d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR

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