FDA Recall D-0510-2024
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class II Ongoing 721 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Reason for recall
Lack of Assurance of Sterility: Leaking vials
Recall record
- Recall number
D-0510-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-05-23
- Classified by FDA Center
- 2024-05-28
- FDA published
- 2024-06-05
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- ZOLEDRONIC ACID
- Generic name(s)
- ZOLEDRONIC ACID
- Manufacturer(s)
- Dr.Reddy's Laboratories Ltd
- NDC(s)
55111-688- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.