Valeant Pharmacueticals International recalls Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos,…

Recall date

January 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1699-2016

FDA classification

Class II

Brand / firm

Valeant Pharmacueticals International

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.