Status
Ongoing
Drug Enforcement D-0510-2024
Lack of Assurance of Sterility: Leaking vials
Classification
Class II
Report Date
June 5, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 13,880 vials
- Reason for recall
- Lack of Assurance of Sterility: Leaking vials
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address
-
107 College Rd E
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0510-2024
- Event ID
- 94686
- Recall initiation date
- May 23, 2024
- Center classification date
- May 28, 2024
- Code info
- Lot #: G3000010, Exp. Date 11/2025
- More code info
- —