FDA-Drug2022-08-17Class III
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Teva Pharmaceuticals USA Inc
Hazard
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Sold states
Distributed in Ohio
Affected count
4162 cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1334-2022Don't want to check this manually?
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