Why it was recalled
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Product description
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
Lot numbers, UPCs & expiration codes
HAD2964A, Exp 7/31/2024
Where it was sold
Nationwide in the USA
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-0582-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 2, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 2088 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0582-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94913
- Address
- 2 Independence Way
- Code information
- HAD2964A, Exp 7/31/2024
- Postal code
- 08540-6620
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0582-2024
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 2088 vials
- Reason for recall
- CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2024