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21,279 catalysts · 4,728 grant · 3,640 device 510k · 3,382 8k filing · 2,970 approval · 2,000 device pma · 2,000 device recall
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21,279 catalysts · 4,728 grant · 3,640 device 510k · 3,382 8k filing · 2,970 approval · 2,000 device pma · 2,000 device recall
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
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: NUW. Advisory committee: Physical Medicine. Type: Traditional
Product code: QLY. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KOJ. Advisory committee: Dental. Type: Traditional
Product code: SEP. Advisory committee: Microbiology. Type: Direct
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QWS. Advisory committee: General Hospital. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: PTF. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OBJ. Advisory committee: Cardiovascular. Type: Special
Product code: POV. Advisory committee: Hematology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Product code: OWQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional