D-1349-2022 Class III Terminated
FDA drug recall D-1349-2022 was initiated by Amerisource Health Services LLC on Jul 27, 2022 and is designated Class III. Reason for recall: Subpotent Drug The recall status is terminated (terminated Sep 28, 2023). Affected quantity: 4,160 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Jul 27, 2022
- Termination Date
- Sep 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,160 vials
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
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: FE22001A, Exp. Date 01/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1349-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026