Why it was recalled
Failed stability specifications
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0576-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 19, 2022
- FDA report date
- Mar 2, 2022
- Quantity
- 18261 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0576-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89447
- Address
- 107 College Rd E
- Code information
- 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.
- Postal code
- 08540-6623
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0576-2022
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 18261 vials
- Termination date
- Dec 13, 2022
- Reason for recall
- Failed stability specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jan 19, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 22, 2022