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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
Product code: PLV. Advisory committee: Dental. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QIT. Advisory committee: OP. Decision: APPR
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff. — Reason: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits. — Status: Ongoing
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205 — Reason: An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user. — Status: Ongoing
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OTIC
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA PHARMACEUTICALS USA INC. Form: SOLUTION. Route: INJECTION
Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 — Reason: Failed Dissolution Specifications — Status: Ongoing
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N — Reason: Marketed Without an Approved NDA/ANDA — Status: Ongoing
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 — Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. — Status: Ongoing
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. — Reason: Subpotent Drug — Status: Ongoing
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 — Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. — Status: Ongoing
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). — Reason: Presence of Particulate Matter: Particulate matter identified as glass — Status: Ongoing
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 — Reason: Lack of Assurance of Sterility. — Status: Ongoing
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Special