Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orapharma (Onpharma) Onset Mixing Pen Rx only Recalled by Valeant Pharmacueticals International Due to It has been determined that the Onset Mixing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Valeant Pharmacueticals International directly.
Affected Products
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.
Quantity: 7,716
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Valeant Pharmacueticals International
Valeant Pharmacueticals International has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report