Class III · Low risk Terminated
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India…
Reason Failed stability specifications
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance
What was recalled
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
- Recalling firm
- Reliance Life Sciences Private Limited
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0673-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bortezomib recalls
See all
Class II · Moderate risk Terminated
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium…
Reason Defective Container: Confirmed reports of loose vial crimps.
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