PlainRecalls
FDA Drug Low Class III Terminated

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

Reported: March 2, 2022 Initiated: January 19, 2022 #D-0576-2022

Product Description

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

Reason for Recall

Failed stability specifications

Details

Units Affected
18261 vials
Distribution
USA Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 18261 vials.
Why was this product recalled?
Failed stability specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on March 2, 2022. Severity: Low. Recall number: D-0576-2022.