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30,864 catalysts · 18,370 approval · 4,524 device 510k · 3,360 grant · 1,902 device recall · 1,703 device pma · 1,005 recall
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30,864 catalysts · 18,370 approval · 4,524 device 510k · 3,360 grant · 1,902 device recall · 1,703 device pma · 1,005 recall
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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
Product code: MRN. Advisory committee: Anesthesiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: LQY. Advisory committee: Unknown. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: KGI. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional