Zoledronic Acid Injection Recalled for Sterility Defect
Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as Class II. No illnesses or injuries are reported in the source. However, leaking sterile injectable vials represent a clear risk of harm through contamination, meeting the criterion for Score 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zoledronic Acid Injection 5mg/100mL manufactured by Dr. Reddy's Laboratories, Inc. has been recalled. The affected product is Lot #G3000010 with expiration date 11/2025, totaling 13,880 single-dose vials. These vials were distributed nationwide within the United States.
The recall is issued due to a lack of assurance of sterility. Specifically, the vials were found to be leaking, which compromises the sterility of the injectable medication.
Zoledronic Acid Injection is administered intravenously and must maintain strict sterility to prevent contamination-related adverse effects in patients. Healthcare facilities, pharmacies, and medical providers who received vials from this lot should be aware of the recall.
The recalled product
- Product
- ZOLEDRONIC ACID (ZOLEDRONIC ACID)
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Intravenous Injectable
- Hazard
- leaking-vials
- sterility-defect
- contamination-risk
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 #: G3000010
- Exp. Date 11/2025
UPCs (1)
- 0355111688525
Distribution
Distributed nationwide across the United States.
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