RecallRadar

FDA Drug recall D-1349-2022

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez,…

On 2022-08-24 the FDA classified a Class III recall of Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez,… by Amerisource Health Services, citing subpotent Drug.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1349-2022
ClassificationClass III
Statusterminated
Initiated2022-07-27
Published2022-08-24
Last updated2026-09-13 11:52 UTC
CompanyAmerisource Health Services
DistributionUS

Product

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

Subpotent Drug

Identifiers

code_infoLot #: FE22001A, Exp. Date 01/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1349-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.