D-0673-2026 Class II Ongoing

Recalled by Reliance Life Sciences Private Limited — Navi Mumbai, N/A

FDA drug recall D-0673-2026 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: 11,400 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
11,400 vials

Product Description

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

Nationwide in the USA

Code Information

Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028