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23,241 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,223 8k filing · 2,000 device pma · 2,000 device recall
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23,241 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,223 8k filing · 2,000 device pma · 2,000 device recall
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Product code: PCC. Advisory committee: Neurology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: QDS. Advisory committee: Pathology. Type: Special
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: AZURITY. Form: TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQP. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QBS. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: MLO. Advisory committee: Cardiovascular. Type: Traditional
Product code: PLF. Advisory committee: Orthopedic. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional