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U.S. Department of Health and Human Services

Class 2 Device Recall Onpharma

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 Class 2 Device Recall Onpharmasee related information
Date Initiated by FirmJanuary 29, 2016
Create DateMay 20, 2016
Recall Status1 Terminated 3 on October 06, 2017
Recall NumberZ-1699-2016
Recall Event ID 73678
Product Classification unknown device name - Product Code N/A
ProductOrapharma (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.
Code Information Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757 
FEI Number 3009443653
Recalling Firm/
Manufacturer		 Valeant Pharmacueticals International
400 Somerset Corporate Blvd
Bridgewater NJ 08807-2867
For Additional Information ContactHunter Manuel
317-957-3319
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionValeant 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.
Quantity in Commerce7,716
DistributionNationwide Distribution
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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