Azacitidine for Injection 100mg/vial Lyophilized Powder recall: Subpotent
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Why was Azacitidine for Injection 100mg/vial Lyophilized Powder recalled?
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: FE22001A, Exp 01/2024
- Product
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Quantity
- 4162 cartons
- Distribution
- Distributed in Ohio
- Recall date
- August 17, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)