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23,283 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,332 8k filing · 2,000 device pma · 2,000 device recall
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23,283 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,332 8k filing · 2,000 device pma · 2,000 device recall
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3 — Reason: Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection). — Status: Terminated
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04 — Reason: cGMP Deviations: Temperature excursion — Status: Terminated
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15. — 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
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Product code: NQX. Advisory committee: Microbiology. Type: Special
Product code: MBH. Advisory committee: Orthopedic. Type: Special
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: BYI. Advisory committee: Anesthesiology. Type: Traditional
Product code: JOP. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: MBB. Advisory committee: Orthopedic. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: ILX. Advisory committee: Physical Medicine. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: EWL. Advisory committee: Ear, Nose, Throat. Type: Traditional
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ALKEM. Form: CAPSULE. Route: ORAL
Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS
Product code: PNR. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: FEB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FPD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PQA. Advisory committee: Microbiology. Type: Special
Product code: QDQ. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BYI. Advisory committee: Anesthesiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional