Dr. Reddy's Azacitidine Injectable Drug Recalled for Failed Stability
Dr. Reddy's Laboratories is recalling Azacitidine 100mg injectable vials nationwide due to failed stability specifications. Multiple lot numbers distributed across the United States are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is stability failure, which is a quality/integrity issue rather than an acute safety threat. The source text contains no evidence of harm or hospitalization.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Azacitidine (azacitidine) 100mg/vial, a prescription injectable medication used intravenously or subcutaneously, due to failed stability specifications.
The recall affects 68,061 vials distributed nationwide in the United States. The affected lots include: H200101, H200102, H200099, H200100, H200106 (expiration 8/1/2023); H210015, H210014, H210013 (expiration 11/1/2023); H210086 (expiration 12/1/2023); H210130 (expiration 1/1/2024); H210171, H210172, H210173, H210174 (expiration 2/1/2024); H210196, H210197 (expiration 3/1/2024); H210283, H210282 (expiration 4/1/2024); and H210382, H210381, H210419, H210420 (expiration 7/1/2024), H210445 (expiration 8/1/2024).
Patients using this medication should contact their healthcare provider or pharmacist to determine if their vial is part of the recall. Healthcare providers should not dispense affected lots. The product is manufactured by Dr. Reddy's Laboratories Limited, Visakhapatnam, India, and bears NDC 43598-305-62.
The recalled product
- Product
- AZACITIDINE (AZACITIDINE)
- Brand
- AZACITIDINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable / Prescription
- Hazard
- stability-failure
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
UPCs (1)
- 0343598305622
Distribution
Distributed nationwide across the United States.
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