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.
FDA Recall Z-1699-2016 · Posted None
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Recalling FirmValeant Pharmacueticals International
Recall StatusTerminated
Product CodeN/A
Date Initiated2016-01-29
Date Terminated2017-10-06
Product Quantity7,716
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.
Firm Action
Valeant sent a letter entitled "Field Correction to Orapharma Onset Mixing Pen," dated 1/29/2016, to customers via UPS. The letter identified the affected device and the issue involved. The firm recommends that users stop using the device if it had been in use for more than 18 months. Customers were to refer to the list of the affected lots to determine if their device needed to be replaced. If the device was one of the ones identified, users were to contact Valeant Pharmaceuticals to arrange for a replacement at no charge. Questions should be directed to customer service 800-321-4576.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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