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Week of Dec 8, 2025

21

Dec 10, 2025recall262d agoGlenmark Pharmaceuticals Inc., USA recall (Cls III)LB PHARMACEUTICALS INC

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. — Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoSafecor Health, LLC recall (Cls II)Mylan Institutional Inc

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B. — Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoPark Avenue Compounding recall (Cls II)Sawai Man Singh Medical College

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1. — Reason: CGMP Deviations — Status: Ongoing

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Dec 10, 2025recall262d 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, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10. — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Status: Ongoing

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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, 2025recall262d 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, 2025recall262d 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, 2025recall262d 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, 2025recall262d 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

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Dec 10, 2025recall262d 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, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 10, 2025recall262d 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

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Dec 12, 2025grant260d agoBOSTON UNIVERSITY MEDICAL CAMPUS — Resilience, cultural alignment, and social support in brain aging: Data from ...

AG grant. $629,111. PI: Astrid M Suchy-Dicey

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Week of Dec 15, 2025

29

Dec 15, 2025grant257d agoJACKSON LABORATORY — Genetic dissection of microglia functions in complement-mediated synapse loss...

AG grant. $716,579. PI: Erik Bradley Bloss

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Dec 15, 2025grant

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