Rayner Pharmaceuticals Limited Issues Defect Notification for Dropodex 0.1% Eye Drops

What Happened

Rayner Pharmaceuticals Limited has informed the Medicines and Healthcare products Regulatory Agency (MHRA) of a defect regarding the product information for Dropodex 0.1% w/v Eye Drops. The company reported that the affected batches do not include the specific concentration of phosphates in the provided product documentation.

Which Products Are Affected

The notification applies to the following product:

• Product Name: Dropodex 0.1% w/v Eye Drops, solution
• Manufacturer: Rayner Pharmaceuticals Limited
• Notification Reference: EL(26)A/10

The MHRA has classified this as a Class 4 Medicines Defect Notification, indicating that the issue is not considered a risk to patient safety that would require a full recall of the product from the market.

What You Should Do

As this is a Class 4 notification, it is primarily intended to inform healthcare professionals and patients of the labeling omission. Consumers using this medication should be aware that the phosphate concentration was missing from the current product information. For further information or specific batch inquiries, consumers may refer to the official MHRA alert or contact Rayner Pharmaceuticals Limited.

Why This Matters

This notification ensures transparency regarding the chemical composition of the eye drops. While the omission of phosphate concentration in the labeling is a regulatory defect, the MHRA has categorized the severity of this issue as low, posing minimal safety impact to the public.

Source

MHRA - Medicines and Healthcare products Regulatory Agency