Recalls / Class II
Class IID-0784-2016
Product
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
- Brand name
- Zoledronic Acid
- Generic name
- Zoledronic Acid
- Active ingredient
- Zoledronic Acid
- Route
- Intravenous
- NDC
- 55111-688
- FDA application
- ANDA091363
- Affected lot / code info
- Lot BS523, exp 10/2017
Why it was recalled
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 3,342 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-03
- FDA classified
- 2016-03-28
- Posted by FDA
- 2016-04-06
- Terminated
- 2017-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0784-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.