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9,817 catalysts · 3,312 8k filing · 2,051 grant · 1,024 approval · 1,000 device adverse event · 741 device 510k · 584 earnings
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9,817 catalysts · 3,312 8k filing · 2,051 grant · 1,024 approval · 1,000 device adverse event · 741 device 510k · 584 earnings
GEM Premier 5000 PAK; Part No. 00055415004. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
GEM Premier 5000; Part No. 00055445010 & 00055445011. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
GEM Premier 5000 PAK; Part No. 00055407504. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
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
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MSD. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: TWI PHARMS. Form: EMULSION. Route: OPHTHALMIC
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: IV (INFUSION)
Sponsor: HISUN PHARM HANGZHOU. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASCENT PHARMS INC. Form: FILM. Route: BUCCAL, SUBLINGUAL
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
Aleve 1's, 60 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
MOTRIN 2'S DISP.- 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN 2'S DISP.- 30 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 — Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. — Status: Ongoing
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
PEPTO BISMOL 32CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each — Reason: cGMP deviations. — Status: Ongoing
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Reason: Presence of Particulate Matter. — Status: Ongoing
NYQUIL COLD & FLU -32CT/2PK — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Claritin, 20 Count, UPC: 655708016305 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01 — Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10. — Reason: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. — Status: Ongoing
Bayer 2Pk- 25 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
PEPCID COMPLETE - 25CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
DAYQUIL COLD & FLU, 32CT/2PK — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing