D-0674-2026 Class II Ongoing
FDA drug recall D-0674-2026 was initiated by Reliance Life Sciences Private Limited on June 24, 2026 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is ongoing. Affected quantity: 8,001 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 15, 2026
- Initiation Date
- June 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,001 vials
Product Description
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Reason for Recall
Lack of Sterility Assurance
Distribution Pattern
Nationwide in the USA
Code Information
Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027