FDA Recalls Onset Mixing Pen Due to Missing Use Period Labeling
Valeant Pharmaceuticals is recalling 7,716 Onset Mixing Pens because the labeling fails to state the 18-month optimal use period from the start of use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error regarding the optimal use period, which fits the rubric criteria for minor labeling errors and low-risk issues without reported injuries.
Plain-English summary
Valeant Pharmaceuticals International is recalling 7,716 units of the Orapharma (Onpharma) Onset Mixing Pen, Product/Part Number 1054-02. The product is a prescription-only device used to dispense a solution from a standard 3 mL size cartridge into a second fluid container. The recall is due to a labeling deficiency where the current instructions for use do not stipulate the device's optimal use period of 18 months from the start of use.
The affected units were distributed nationwide. The recall includes specific Dosing Mechanism Lots: 14090, 14452, 17133, 18004, 18403, 18583, and 18757. The device was manufactured for Onpharma Inc. in Los Gratos, CA.
Consumers and healthcare providers should check their inventory for the affected lot numbers. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Valeant Pharmacueticals International
- Category
- Medical Device — Dosing Device
- Hazard
- Affected units
- 7,716
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
Distribution
Distributed nationwide across the United States.
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