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3,998 catalysts · 4,728 grant · 3,890 device 510k · 3,063 approval · 3,057 8k filing · 2,000 device pma · 2,000 device recall
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3,998 catalysts · 4,728 grant · 3,890 device 510k · 3,063 approval · 3,057 8k filing · 2,000 device pma · 2,000 device recall
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Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: AVANTHI INC. Form: TABLET. Route: ORAL
Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL
Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 — Reason: CGMP Deviations: lack of adequate release testing. — Status: Ongoing
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 — Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed — Status: Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 — Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide — Status: Ongoing
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. — Reason: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet — Status: Completed
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL
Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 — Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. — Status: Terminated
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit — Status: Terminated
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed. — Status: Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL
Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. — Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. — Status: Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 — Reason: Superpotent; sodium benzoate preservative — Status: Completed
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Status: Ongoing