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
Reported: April 6, 2016 Initiated: March 3, 2016 #D-0784-2016
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 3,342 vials
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 3,342 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 6, 2016. Severity: Moderate. Recall number: D-0784-2016.
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