Orapharma recall: Labeling Error
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…
Why was Orapharma 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
- 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…
- Recalling firm
- Valeant Pharmacueticals International
- Quantity
- 7,716
- Distribution
- Nationwide Distribution
- Recall date
- May 25, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)