Calendar

pharmadog

Week of Feb 2, 2026

Feb 4, 2026approval189d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Feb 4, 2026approval189d agoCARBOPLATIN — FDA approvalOncotelic Therapeutics, Inc.

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 4, 2026recall189d agoHaleon US Holdings LLC recall (Cls III)

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoBaxter Healthcare Corporation recall (Cls II)Baxter Healthcare Corp

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoNOVADOZ PHARMACEUTICALS LLC recall (Cls III)Novadoz Pharmaceuticals LLC

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoGreenstone Llc recall (Cls II)Greenstone LLC

methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall189d agoSato Pharmaceutical Co., Ltd recall (Cls II)TAKEDA PHARMACEUTICAL CO LTD

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026device 510k189d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Signature ONE System (510k cleared)

Product code: QHE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoSpinal Elements, Inc. — Luna® Ti Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoBard Peripheral Vascular, Inc. — UltraScore Focused Force PTA Balloon (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoZimmer, Inc. — G7® Revision Acetabular System (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoYadu Medical (Henan) Co., Ltd. — Henan Yadu Level 4 Surgical Gowns (Reinforced) (510k cleared)

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

full page →fda device 510k ↗

Feb 4, 2026device 510k189d agoEvolution Spine — E3D-C Interbody System (510k cleared)

Product code: OVE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device pma189d agoInstylla, Inc. — Embrace Hydrogel Embolic System (PMA supplement)

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

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Corp. — MENTOR MemoryGel Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Worldwide, LLC — MENTOR MemoryShape Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedtronic, Inc. — Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Feb 4, 2026device pma189d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Feb 4, 2026device pma189d agoMedtronic, Inc. — Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Feb 4, 2026device recall189d agoDiagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing

full page →fda device recalls ↗

Feb 4, 2026grant189d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Discovery and evolution of mammalian Serpins as host-encoded viral protease i...University of California San Diego

AI grant. $439,250. PI: Matthew Daugherty

Week of Feb 2, 2026