RecallRadar

FDA Drug recall D-0575-2022

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd

On 2022-03-02 the FDA classified a Class III recall of Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd by Dr Reddy S Laboratories, citing failed stability specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0575-2022
ClassificationClass III
Statusterminated
Initiated2022-01-19
Published2022-03-02
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionUS

Product

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

Reason

Failed stability specifications

Identifiers

ndc43598-305-62
code_info
Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086,…Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024; H210283 & H210282, Exp 4/1/2024; H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024.

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-0575-2022%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.