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23,404 catalysts · 5,000 device 510k · 4,728 grant · 3,696 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
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23,404 catalysts · 5,000 device 510k · 4,728 grant · 3,696 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
Sponsor: SOBI. Form: CAPSULE. Route: ORAL
Product code: DQO. Advisory committee: Cardiovascular. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: SDC. Advisory committee: General Hospital. Type: Direct
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DRG. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. — Reason: Crystallization — Status: Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles). — Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. — Reason: Failed Impurities/Degradation Specification — Status: Ongoing
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 — Reason: Labeling: Missing Label — Status: Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155 — Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Status: Ongoing
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317 — Reason: Presence of Particulate Matter: Presence of glass particulates. — Status: Terminated
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018 — Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. — Reason: Failed Impurities/Degradation Specification — Status: Ongoing
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: SDG. Advisory committee: Neurology. Type: Direct
Product code: FRO. Advisory committee: Unknown. Type: Special
Product code: OPP. Advisory committee: General Hospital. Type: Special
Product code: OLK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: CAH. Advisory committee: Anesthesiology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: SYNDAX. Form: TABLET. Route: ORAL
Product code: OTM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional