Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by...
FDA Recall #D-1349-2022 — Class III — July 27, 2022
Product Description
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Reason for Recall
Subpotent Drug
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,160 vials
Distribution
Nationwide within the USA
Code Information
Lot #: FE22001A, Exp. Date 01/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated