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2,316 catalysts · 3,057 8k filing · 2,096 grant · 1,160 approval · 1,000 device adverse event · 874 device 510k · 623 device pma
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2,316 catalysts · 3,057 8k filing · 2,096 grant · 1,160 approval · 1,000 device adverse event · 874 device 510k · 623 device pma
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DA grant. $49,538. PI: Lily Torp
NS grant. $74,632. PI: THADDEUS KUNKEL
NS grant. $50,000. PI: Huaye Zhang
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. — Status: Ongoing
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — Reason: Lack of Assurance of Sterlity — Status: Ongoing
CA grant. $49,538. PI: Hina Shah
NS grant. $567,047. PI: David Matthew Smith
GM grant. $140,056. PI: Ruby Fried
GM grant. $312,417. PI: Dorian R Dodd
AI grant. $39,066. PI: Brooke Ring
AI grant. $75,052. PI: Sarah C Feid
GM grant. $132,469. PI: Martha Rojo
HD grant. $248,995. PI: Thoa Khuu
NS grant. $579,610. PI: Pau Castel
HL grant. $469,049. PI: nagendra monangi
HL grant. $154,846. PI: HELAINE E. RESNICK
HL grant. $129,024. PI: DEDRA S BUCHWALD
AI grant. $87,244. PI: Jenny Ann Buczek
DK grant. $450,479. PI: Zhijian Qian
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1 — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
GM grant. $196,875. PI: Stephania A Cormier
AG grant. $293,454. PI: Caitlin R. Bowman
GM grant. $223,500. PI: KayLoni L. Olson
NS grant. $943,253. PI: Hideho Okada
DE grant. $699,184. PI: Sukirth Murthy Ganesan
AG grant. $466,125. PI: Valentina Mazzoli
AG grant. $476,159. PI: Martin Hruska
GM grant. $1. PI: Katherine Carmen Forbes
AG grant. $560,380. PI: Stephanie Grace Cone
AG grant. $690,865. PI: Alan A. Cohen
AG grant. $580,636. PI: Adriana San Miguel
AG grant. $446,875. PI: Eleonora Scorletti
DK grant. $676,279. PI: Javier Garcia Bermudez
AG grant. $642,063. PI: Jayeeta Basu
AG grant. $556,121. PI: Eric Lieberman Greer
NS grant. $186,250. PI: Jacques Wadiche
AG grant. $1,468,868. PI: ANNE BRUNET