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30 catalysts · 16 device 510k · 9 device pma · 4 recall · 1 approval
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30 catalysts · 16 device 510k · 9 device pma · 4 recall · 1 approval
Sponsor: HIKMA. Form: TABLET. Route: ORAL
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295 — Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. — Status: Completed
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 — Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). — Status: Ongoing
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25 — Reason: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. — Status: Ongoing
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 — Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. — Status: Completed
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: SAZ. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LOZ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPS. Advisory committee: CV. Decision: OK30
Product code: NKG. Advisory committee: Orthopedic. Type: Special
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GKZ. Advisory committee: Hematology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: IMJ. Advisory committee: Physical Medicine. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional
Product code: GKZ. Advisory committee: Hematology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Special