Bortezomib for Injection Recalled Due to Lack of Sterility Assurance
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable drug product. Lack of sterility assurance in injectable medications presents significant health risk due to potential for serious infection, particularly in vulnerable patient populations. Class II recalls are classified as Severe per the rubric.
Plain-English summary
Reliance Life Sciences Private Limited is recalling Bortezomib for Injection 3.5mg/Vial, 10 mL per single-dose vial, manufactured for Somerset Therapeutics, LLC, due to lack of sterility assurance. The recall affects approximately 11,400 vials distributed nationwide in the USA.
The affected lot numbers are RBIH0125A (expiry Jan 31, 2028), RBIH0225A (expiry Feb 29, 2028), RBIH0325A (expiry Feb 29, 2028), and RBIH0525A (expiry Mar 31, 2028). The NDC number is 70069-0836-01.
Bortezomib is an intravenous or subcutaneous injectable medication. Products that fail sterility assurance may pose a risk of contamination. Healthcare providers and patients should stop using affected lots and contact their supplier or the manufacturer for guidance on replacement or alternative treatment options.
The recalled product
- Product
- 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
- Manufacturer
- Reliance Life Sciences Private Limited
- Affected units
- 11,400
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 (6)
- Lot
- expiry: RBIH0125A Jan 31
- 2028
- RBIH0225A Feb 29
- RBIH0325A Feb 29
- RBIH0525A Mar 31
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Reliance Life Sciences Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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