FDAFDA · Food and drugs·Recall number D-0784-2016
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Published April 6, 2016 · Recall initiated: March 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide
- UPC
- 0355111688525
- Lot
- Lot BS523, exp 10/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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