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22,351 catalysts · 4,728 grant · 4,406 device 510k · 3,286 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
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22,351 catalysts · 4,728 grant · 4,406 device 510k · 3,286 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 — Reason: Labeling: Label Mix-Up — Status: Ongoing
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: JXM. Advisory committee: Clinical Toxicology. Type: Special
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: DZJ. Advisory committee: Dental. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXZ. Advisory committee: Neurology. Type: Traditional
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Product code: EBD. Advisory committee: Dental. Type: Traditional
Product code: GWL. Advisory committee: Neurology. Type: Special
Product code: OPT. Advisory committee: Ophthalmic. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: FZE. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: GWF. Advisory committee: Neurology. Type: Special
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: MNS. Advisory committee: Anesthesiology. Type: Traditional
Product code: MNT. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: FER. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: MWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: OBO. Advisory committee: Ophthalmic. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Special