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17 catalysts · 7 approval · 7 device 510k · 3 recall
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17 catalysts · 7 approval · 7 device 510k · 3 recall
Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL
Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 — Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. — Status: Completed
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