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21,774 catalysts · 4,728 grant · 4,110 device 510k · 3,180 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,774 catalysts · 4,728 grant · 4,110 device 510k · 3,180 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. — Reason: Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality. — Status: Completed
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. — Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. — Status: Ongoing
Product code: HWC. Advisory committee: Orthopedic. Type: Special
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: QSZ. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: CGR. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GBM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: SCPHARMACEUTICALS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TORRENT. Form: CAPSULE. Route: ORAL
Sponsor: TORRENT. Form: CAPSULE. Route: ORAL
Sponsor: TORRENT. Form: CAPSULE. Route: ORAL
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: LON. Advisory committee: Microbiology. Type: Special
Product code: QNI. Advisory committee: Orthopedic. Type: Traditional
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Product code: POS. Advisory committee: Neurology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: FLE. Advisory committee: General Hospital. Type: Special
Product code: LQY. Advisory committee: Unknown. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: BSK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NPM. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL