D-0577-2022 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

FDA drug recall D-0577-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 19, 2022 and is designated Class III. Reason for recall: Failed stability specifications The recall status is terminated (terminated Dec 13, 2022). Affected quantity: 2,980 vials.

Recall Details

Product Type
Drugs
Report Date
Mar 2, 2022
Initiation Date
Jan 19, 2022
Termination Date
Dec 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,980 vials

Product Description

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

Reason for Recall

Failed stability specifications

Distribution Pattern

USA Nationwide

Code Information

Lot # H210233, Exp 3/1/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0577-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.