Valeant Pharmacueticals International: Medical Device Recall in 2016 - (Recall #: Z-1699-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 29, 2016

Date Posted: May 25, 2016

Recall Number: Z-1699-2016

Event ID: 73678

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.

Status: Terminated

Product Quantity: 7,716

Code Information:

Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated