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7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
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7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Allura Xper FD20/20 OR Table; System Code: 722039; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Allura Xper FD20/15; System Code: 722058; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Allura Xper FD20/20; System Code: 722038; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Allura Xper FD10C; System Code: 722001; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing
EB grant. $542,947. PI: Brett C Byram
DA grant. $101,214. PI: Jason Richard Paris
AI grant. $19,000. PI: Nicole Franziska Steinmetz
CA grant. $10,000. PI: TERRY L. SHEPPARD
DK grant. $796,370. PI: Erin Frazee Barreto
CA grant. $5,000. PI: TERRY L. SHEPPARD
MH grant. $416,859. PI: Hongbing Wang
HG grant. $785,329. PI: Kevin Daniel Corbett
Sponsor: PROVEPHARM SAS. Form: INJECTABLE. Route: INJECTION
Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. — Status: Ongoing
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. — Status: Ongoing
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. — Status: Ongoing
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PBQ. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: QXN. Advisory committee: Ear, Nose, Throat. Type: Direct
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: PNN. Advisory committee: Dental. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Special