Azacitidine for Injection Recalled for Lack of Sterility Assurance
Reliance Life Sciences is recalling Azacitidine for Injection 100mg/Vial nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug product. Lack of sterility assurance in injectable drugs poses a direct risk of serious infection or harm to patients. FDA Class II recalls of drugs are scored at 4 (Severe) per the rubric.
Plain-English summary
Reliance Life Sciences Private Limited is recalling Azacitidine for Injection 100mg/Vial (NDC 70069-0857-01), manufactured for Somerset Therapeutics, LLC, due to lack of sterility assurance. The affected product is distributed nationwide across the United States.
The recall involves approximately 8,001 vials across twelve lots with expiration dates ranging from June 30, 2027 through September 30, 2027. Affected lot numbers are: RAZM0425A, RAZM0525A, RAZM0725A, RAZM0825A, RAZM0925A, RAZM1125A, RAZM1225A, RAZM1425A, RAZM1525A, RAZM1625A, RAZM1725A, and RAZM2025A.
Azacitidine is a prescription injection used for subcutaneous and intravenous administration. Patients who have received this medication should immediately contact their healthcare provider to discuss the recall and any potential health concerns. Healthcare providers should verify lot numbers and contact their suppliers regarding return or replacement of affected product.
The recalled product
- Product
- 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
- Manufacturer
- Reliance Life Sciences Private Limited
- Category
- Drug — Injectable / Oncology
- Hazard
- lack-of-sterility
- contamination-risk
- infection-risk
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 (14)
- Lot
- expiry: RAZM0425A Jun 30
- 2027
- RAZM0525A Jun 30
- RAZM0725A Jun 30
- RAZM0825A Jun 30
- RAZM0925A Jul 31
- RAZM1125A Jul 31
- RAZM1225A Jul 31
- RAZM1425A Jul 31
- RAZM1525A Jul 31
- RAZM1625A Aug 31
- RAZM1725A Aug 31
- RAZM2025A Sep 30
Distribution
Distributed nationwide across the United States.
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