Recall: D-1334-2022

Class III - Minor Violations

Class IIIClassification

2022-07-22Initiated

TerminatedStatus

Teva Pharmaceuticals USA IncFirm

Product

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Reason

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Distribution

Distributed in Ohio

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.