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21,216 catalysts · 4,728 grant · 3,704 device 510k · 3,189 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
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21,216 catalysts · 4,728 grant · 3,704 device 510k · 3,189 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: AZURITY. Form: SOLUTION. Route: ORAL
Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS
Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 — Reason: Failed Dissolution Specifications — Status: Ongoing
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