Recalls / Class III
Class IIID-0576-2022
Product
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
- Brand name
- Azacitidine
- Generic name
- Azacitidine
- Active ingredient
- Azacitidine
- Route
- Intravenous, Subcutaneous
- NDC
- 43598-465
- FDA application
- ANDA201537
- Affected lot / code info
- Lot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024.
Why it was recalled
Failed stability specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 18261 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-01-19
- FDA classified
- 2022-02-22
- Posted by FDA
- 2022-03-02
- Terminated
- 2022-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0576-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.