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2,294 catalysts · 3,288 8k filing · 2,079 grant · 1,097 approval · 1,000 device adverse event · 800 device 510k · 584 earnings
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2,294 catalysts · 3,288 8k filing · 2,079 grant · 1,097 approval · 1,000 device adverse event · 800 device 510k · 584 earnings
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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
DK grant. $686,129. PI: Markus Grompe
DE grant. $419,375. PI: Kelly Christine Rice
NS grant. $126,900. PI: Eddy Albarran
EY grant. $76,120. PI: Sofia Krasovskaya
AI grant. $33,538. PI: Alexandra Tabachnikova
DE grant. $78,840. PI: Hagar Kenawy
NS grant. $674,950. PI: ZHIGANG HE
DE grant. $435,875. PI: Santiago Orrego
HL grant. $49,538. PI: Vasundhara Singh
NS grant. $120,582. PI: Kiah Hardcastle
CA grant. $87,964. PI: Katherine Ismei Zhou
AR grant. $15,000. PI: JOY Y WU
AI grant. $40,833. PI: Nicholas N Jarjour
TR grant. $18,100. PI: TERRY L. SHEPPARD
DK grant. $41,998. PI: Morgan E. Smith
NS grant. $670,266. PI: Jaroslav Bendl
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LIQUID DAYQUIL 12/8oz — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN MIGRAINE 2'S- 25 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Swan, White Clear Alcohol, 50%, 16oz, 12 count — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing