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20,237 catalysts · 4,728 grant · 3,175 device 510k · 3,086 8k filing · 2,805 approval · 2,000 device pma · 2,000 device recall
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20,237 catalysts · 4,728 grant · 3,175 device 510k · 3,086 8k filing · 2,805 approval · 2,000 device pma · 2,000 device recall
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Special
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: DSA. Advisory committee: Cardiovascular. Type: Special
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Special
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: DSH. Advisory committee: Cardiovascular. Type: Traditional
Product code: POV. Advisory committee: Hematology. Type: Dual Track
Product code: GZI. Advisory committee: Neurology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: FBO. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Special
Product code: QNM. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: DSH. Advisory committee: Cardiovascular. Type: Traditional
Product code: EBZ. Advisory committee: Dental. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: MLW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: EBG. Advisory committee: Dental. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Product code: PZO. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INJECTION
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 — Reason: Subpotent — Status: Ongoing
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14. — Reason: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. — Status: Ongoing
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01 — Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. — Status: Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. — Reason: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. — Status: Ongoing