FDA recall D-0784-2016

Dr. Reddy's Laboratories, Inc. · Class II · drug

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

Reason for recall

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-03-03
Report date: 2016-04-06
Termination date: 2017-05-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0784-2016