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21,576 catalysts · 4,728 grant · 3,840 device 510k · 3,368 8k filing · 3,044 approval · 2,000 device pma · 2,000 device recall
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21,576 catalysts · 4,728 grant · 3,840 device 510k · 3,368 8k filing · 3,044 approval · 2,000 device pma · 2,000 device recall
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Product code: PHL. Advisory committee: Physical Medicine. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Special
Product code: IPL. Advisory committee: Physical Medicine. Type: Traditional
Product code: GWL. Advisory committee: Neurology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: MUE. Advisory committee: Radiology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PRD. Advisory committee: Immunology. Type: Traditional
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL
Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL
Sponsor: ALVOGEN. Form: TABLET. Route: ORAL
Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: LXC. Advisory committee: Unknown. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Special
Product code: HBE. Advisory committee: Neurology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MCW. Advisory committee: Cardiovascular. Type: Special
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Product code: PGM. Advisory committee: Orthopedic. Type: Traditional
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OZE. Advisory committee: Microbiology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional