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21,732 catalysts · 4,728 grant · 4,110 device 510k · 3,126 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,732 catalysts · 4,728 grant · 4,110 device 510k · 3,126 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PRE. Advisory committee: Microbiology. Type: Traditional
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LCJ. Advisory committee: Unknown. Type: Special
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Product code: IRP. Advisory committee: Physical Medicine. Type: Special
Product code: NOU. Advisory committee: Anesthesiology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Special
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Special
Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: QPC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: MRD. Advisory committee: Unknown. Type: Traditional
Product code: PNG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: KWQ. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: CEM. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters). — Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. — Status: Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 — Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. — Status: Terminated
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 — Reason: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. — Status: Ongoing
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05. — Reason: Failed Stability Specifications — Status: Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ — Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia. — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine — Status: Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters). — Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. — Status: Ongoing
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 — Reason: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. — Status: Ongoing
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India — Reason: CGMP Deviations — Status: Ongoing
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ — Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing