Reported Apr 6, 2016 · Terminated
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd
- ByGland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
- Lot codes and dates
Lot BS523exp 10/2017
- Amount recalled
- 3,342 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
This product could cause temporary or reversible health problems — stop using it.
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