Zoledronic Acid Injection recalled over sterility concerns
- Recall date
- March 3, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D…
- Recall number
- D-0784-2016
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
Get recall alerts
Free email alert whenever Dr. Reddy's Laboratories, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Dr. Reddy's Laboratories, Inc.