Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx onl
Summary
The FDA issued a Class II for Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For S by Reliance Life Sciences Private Limited. Reason: Lack of Sterility Assurance.
Details
Source
Drug Recall
External ID
D-0674-2026
Action Date
2026-07-15
Status
Ongoing
Category
drug
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
Lot/Code Info: 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
Quantity Affected: 8,001 vials
Reason for Recall
Lack of Sterility Assurance
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
Navi Mumbai, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Reliance Life Sciences Private Limited has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Reliance Life Sciences Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Reliance Life Sciences Private Limited have FDA actions?
Reliance Life Sciences Private Limited has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0674-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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