Recalls / Class III
Class IIID-0577-2022
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
- Affected lot / code info
- Lot # H210233, Exp 3/1/2023
Why it was recalled
Failed stability specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 2,980 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-01-19
- FDA classified
- 2022-02-22
- Posted by FDA
- 2022-03-02
- Terminated
- 2022-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0577-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.