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3,407 catalysts · 4,728 grant · 3,048 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
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3,407 catalysts · 4,728 grant · 3,048 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
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Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AZURITY. Form: SOLUTION. Route: ORAL
Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). — Reason: cGMP deviations — Status: Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 — Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol — Status: Ongoing
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4 — Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally. — Status: Ongoing
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL
Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL
Sponsor: IMMUNEX. Form: SYRINGE
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7. — Reason: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents. — Status: Ongoing
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15 — Reason: Failed Dissolution Specifications — Status: Ongoing
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. — Status: Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68 — Reason: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. — Status: Ongoing
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 — Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule — Status: Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. — Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. — Status: Ongoing
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. — Status: Ongoing
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 — Reason: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules — Status: Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88 — Reason: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. — Status: Ongoing
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. — Status: Ongoing
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. — Status: Ongoing
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. — Status: Ongoing
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44. — Reason: Presence of a foreign substance: black hair found embedded in tablet. — Status: Ongoing
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90 — Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. — Status: Ongoing
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX INC. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL