| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-01468-1 |
| Product Name/Description |
METHOPT TEARS - Viscous eye drops with hypromellose 0.5mg/mL
Batch number: 200617
ARTG 146767
(Mylan Health Pty Ltd- Lubricant, eye) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/01/2021 |
| Responsible Entity |
|
| Reason/Issue |
Mylan Health has identified that the label of METHOPT TEARS batch 200617 states hypromellose 0.5mg/mL. The correct strength is 5mg/mL. The product also contains benzalkonium chloride as a preservative, which has inadvertently been removed from the current label. Please note there has been no change to the product formulation or strength. Dose instructions are present on the label and are correct. |
| Recall Action |
Recall |
| Recall Action Instructions |
Wholesalers are advised to quarantine any impacted stock on site and return to the sponsors allocated location.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1 800 274 276 - Mylan Health Customer Service |