The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0577-2022·Announced 2022-03-02

Bortezomib 3.5 mg Vials Recalled Due to Failed Stability Specifications

Dr. Reddy's Laboratories is recalling Bortezomib 3.5 mg single-dose vials nationwide due to failed stability specifications. Approximately 2,980 vials of lot H210233 (expiration 3/1/2023) are affected.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving failed stability specifications—a manufacturing or quality control defect without reported illnesses or injuries. Class III recalls are typically scored 1 or 2; the specificity of the quality failure and pharmaceutical context warrants a score of 2 rather than 1.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Bortezomib 3.5 mg/vial, single-dose vials manufactured in Visakhapatnam, India (NDC 43598-865-60) distributed nationwide in the United States.

The recall is being issued because the product failed to meet stability specifications. Approximately 2,980 vials of lot number H210233, with an expiration date of March 1, 2023, are subject to this recall.

Patients and healthcare providers who have this product should not use it and should contact their pharmacy or healthcare provider for guidance. The product should be quarantined and not dispensed or used.

Healthcare providers and patients with questions should contact Dr. Reddy's Laboratories customer service for instructions on return or destruction of the product.

The recalled product

Product
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Oncology Injectable
Hazard
Affected units
2,980

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 (2)

  • Lot # H210233
  • Exp 3/1/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Dr. Reddy's Laboratories, Inc. 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.

See all 3 products in this recall →

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