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.
What this means for you
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
- stability-failure
- quality-defect
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.
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