Dr. Reddy's Laboratories, Inc.: 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

Is my product affected?

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

• Brand AZACITIDINE

Check against the official notice below — it lists the full affected range.

What happened

Dr. Reddy's Laboratories, Inc. is recalling Azacitidine 100mg/vial, a prescription medication manufactured in India, due to failed stability specifications. The recall affects 68,061 vials distributed nationwide across multiple lot numbers with expiration dates ranging from August 2023 through August 2024.

The affected lot numbers are: H200101, H200102, H200099, H200100, H200106, H210015, H210014, H210013, H210086, H210130, H210171, H210172, H210173, H210174, H210196, H210197, H210283, H210282, H210382, H210381, H210419, H210420, and H210445. The source document does not specify what consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed stability specifications

Details from the source

Reason for recall: Failed stability specifications Distribution: USA Nationwide Quantity: 68061 vials Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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