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28,212 catalysts · 17,794 approval · 4,104 device 510k · 2,472 grant · 1,580 device recall · 1,358 device pma · 904 recall
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28,212 catalysts · 17,794 approval · 4,104 device 510k · 2,472 grant · 1,580 device recall · 1,358 device pma · 904 recall
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit — Status: Terminated
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed. — Status: Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ISA. Advisory committee: Physical Medicine. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: SAQ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: QWH. Advisory committee: Clinical Chemistry. Type: Traditional
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional