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20,220 catalysts · 4,728 grant · 3,163 device 510k · 3,086 8k filing · 2,805 approval · 2,000 device pma · 2,000 device recall
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20,220 catalysts · 4,728 grant · 3,163 device 510k · 3,086 8k filing · 2,805 approval · 2,000 device pma · 2,000 device recall
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
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01 — Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. — Status: Ongoing
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial). — Reason: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15 — Reason: Subpotent — Status: Ongoing
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1 — Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. — Status: Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] — Reason: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. — Status: Ongoing
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03. — Reason: cGMP Deviations — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 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 16729-448-17. — Reason: Subpotent — Status: Ongoing
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01 — Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 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 16729-447-17 — Reason: Subpotent — Status: Ongoing
Product code: KTT. Advisory committee: Orthopedic. Type: Special
Product code: PHR. Advisory committee: Dental. Type: Traditional
Product code: JCX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MOB. Advisory committee: Immunology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NVK. Advisory committee: General, Plastic Surgery. Type: Traditional