FDAFDA · Food and drugs·Recall number D-1334-2022
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Published August 17, 2022 · Recall initiated: July 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZACITIDINE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Distributor
- Distributed in Ohio
- UPC
- 0368001313568
- Lot
- Lot: FE22001A, Exp 01/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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