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Week of Oct 13, 2025

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Oct 14, 2025device pma304d agoAdvanced Bionics — HiResolution Bionic Ear System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

full page →fda device pma ↗

Oct 14, 2025device recall304d agoBecton Dickinson & Company device recall (Cls II)BECTON DICKINSON & CO

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; — Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. — Status: Ongoing

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Oct 14, 2025device recall304d agoOlympus Corporation of the Americas device recall (Cls II)

Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. — Reason: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users. — Status: Ongoing

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Oct 14, 2025device recall304d agoBeckman Coulter Ireland, Inc. device recall (Cls II)

BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. — Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. — Status: Ongoing

full page →fda device recalls ↗

Oct 15, 2025approval303d agoCELECOXIB — FDA approvalCelebrex

Sponsor: YILING. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 15, 2025approval303d agoCELECOXIB — FDA approvalCelebrex

Sponsor: YILING. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 15, 2025approval303d agoFINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approvalfenfluramine hydrochloride

Sponsor: UCB INC. Form: SOLUTION. Route: ORAL

full page →fenfluramine hydrochloride →fda approvals ↗

Oct 15, 2025approval303d agoLACOSAMIDE — FDA approvalLACOSAMIDE

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LACOSAMIDE →fda approvals ↗

Oct 15, 2025approval303d agoLACOSAMIDE — FDA approvalLACOSAMIDE

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LACOSAMIDE →fda approvals ↗

Oct 15, 2025approval303d agoLACOSAMIDE — FDA approvalLACOSAMIDE

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LACOSAMIDE →fda approvals ↗

Oct 15, 2025approval303d agoLACOSAMIDE — FDA approvalLACOSAMIDE

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LACOSAMIDE →fda approvals ↗

Oct 15, 2025approval303d agoLACOSAMIDE — FDA approvalLACOSAMIDE

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →LACOSAMIDE →fda approvals ↗

Oct 15, 2025approval303d agoCONJUGATED ESTROGENS (ESTROGENS, CONJUGATED) — FDA approvalIngenus Pharmaceuticals LLC

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

full page →fda approvals ↗

Oct 15, 2025approval303d agoCONJUGATED ESTROGENS (ESTROGENS, CONJUGATED) — FDA approvalIngenus Pharmaceuticals LLC

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

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Oct 15, 2025approval303d ago— FDA approvalMerck Sharp & Dohme LLC

Sponsor: MERCK SHARP AND DOHME LLC

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Oct 15, 2025approval303d agoLYTGOBI (FUTIBATINIB) — FDA approvalfutibatinib

Sponsor: TAIHO ONCOLOGY. Form: TABLET. Route: ORAL

full page →futibatinib →fda approvals ↗

Oct 15, 2025approval303d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 15, 2025approval303d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

Oct 15, 2025approval303d agoAMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE) — FDA approvalamlodipine besylate

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →amlodipine besylate →fda approvals ↗

Oct 15, 2025approval303d agoAMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE) — FDA approvalamlodipine besylate

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →amlodipine besylate →fda approvals ↗

Oct 15, 2025approval303d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Baylor College of Medicine

Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Tsuno Rice Fine Chemicals Co Ltd

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)EVER Neuro Pharma GmbH

Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Baudax Bio Inc

N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Nexus Pharmaceuticals Inc

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoAvKARE recall (Cls II)AvKare LLC

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28 — Reason: Failed Content Uniformity Specifications — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Eli Lilly and Co

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)University of Colorado Denver

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)PharmaTher Holdings Ltd

BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoAcella Pharmaceuticals, LLC recall (Cls II)LIPELLA PHARMACEUTICALS INC.

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. — Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)Tsuno Rice Fine Chemicals Co Ltd

Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall303d agoGenoGenix LLC recall (Cls II)

Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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