Z-1699-2016Class II

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc...

Name: Z-1699-2016 Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc...
Creator: Valeant Pharmacueticals International
Published: 2016-01-29
License: https://open.fda.gov/license/

Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) / initiated 2016-01-29 / Terminated / root cause: labeling and UDI

FDA source

Valeant Pharmacueticals International began a recall of 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... on 2016-01-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1699-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-05-20
Terminated: 2017-10-06
Recalling firm: Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)
Product: 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 code: N/A
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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.
Quantity in commerce: 7,716
Distribution: Nationwide Distribution
Product codes and lots: Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1699-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-19

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)