Prescription Injectable Azacitidine Recalled for Subpotent Assay Results
Teva Pharmaceuticals recalls Azacitidine for Injection in Ohio after stability testing revealed the drug potency fell below specification standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class III recall is based on a manufacturing quality defect (subpotency) discovered during proactive stability monitoring, with no reported illnesses or adverse events. Class III recalls are typically scored 1–2, and the absence of reported harm places this at the moderate level for a precautionary quality issue.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Azacitidine for Injection 100 mg/vial (Lot FE22001A, expiring January 2024) distributed in Ohio. During a stability monitoring study, the manufacturer discovered that the drug's potency assay fell below specification requirements.
Azacitidine is administered intravenously or subcutaneously. When a drug's potency falls below specification, patients may not receive the intended therapeutic dose. Approximately 4,162 cartons were distributed in the affected lot.
Patients currently using this medication should not stop treatment without consulting their healthcare provider. Those who have this product should verify with their pharmacy or healthcare provider whether their supply is from the affected lot and discuss any appropriate medical follow-up or replacement.
The recalled product
- Product
- AZACITIDINE (AZACITIDINE)
- Brand
- AZACITIDINE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Injectable
- Hazard
- subpotency
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: FE22001A
- Exp 01/2024
UPCs (1)
- 0368001313568
Distribution
Distribution scope not specified by the agency.
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