recall
saveACCORD HEALTHCARE, INC. recall (Cls II)
community read0 votes
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
view source ↗Data sources
last refreshed 26m ago
Found something off?
same company · ±60 days · 4
- recallACCORD HEALTHCARE, INC. recall (Cls II)Nov 6, 2024
- recallACCORD HEALTHCARE, INC. recall (Cls II)Nov 6, 2024
- device 510kOmron Healthcare, Inc. — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) (510k cleared)Oct 8, 2024
- recallACCORD HEALTHCARE, INC. recall (Cls II)Dec 11, 2024
comments(0)
5-min edit window · permanent after that