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21,764 catalysts · 4,728 grant · 4,078 device 510k · 3,203 8k filing · 3,117 approval · 2,000 device pma · 2,000 device recall
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21,764 catalysts · 4,728 grant · 4,078 device 510k · 3,203 8k filing · 3,117 approval · 2,000 device pma · 2,000 device recall
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
Clonazepam Orally Disintegrating Tablet, USP, 2 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#: 49884-310-02 (carton), NDC#: 49884-310-52 (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
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10 — Reason: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. — Status: Terminated
Clonazepam Orally Disintegrating Tablets, USP, 0.25 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#: 49884-307-02 (carton), NDC #: 49884-307-52 (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
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 — Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Product code: QQX. Advisory committee: Microbiology. Type: Dual Track
Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PHN. Advisory committee: Unknown. Type: Traditional
Product code: PZX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: NVP. Advisory committee: Anesthesiology. Type: Traditional
Product code: PLQ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: QJU. Advisory committee: Radiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: DRE. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: JPA. Advisory committee: Hematology. Type: Special
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS
Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL
Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Special
Product code: QBC. Advisory committee: Neurology. Type: Special
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: MUE. Advisory committee: Radiology. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: QGL. Advisory committee: Neurology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Special
Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QEP. Advisory committee: Microbiology. Type: Dual Track
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS
Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL
Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Traditional