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D-0510-2024Class II

Dr. Reddy's Laboratories, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-06-05
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
13,880 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Leaking vials

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

Code / lot info

Lot #: G3000010, Exp. Date 11/2025

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →