Home / Recalls / Valeant Pharmacueticals International / Z-1699-2016

Z-1699-2016 Class II Terminated

Recalled by Valeant Pharmacueticals International — Bridgewater, NJ

Recall Details

Product Type: Devices
Report Date: May 25, 2016
Initiation Date: January 29, 2016
Termination Date: October 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,716

Product Description

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

Reason for Recall

It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

Distribution Pattern

Nationwide Distribution

Code Information

Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757