| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2018-RN-00042-1 |
| Product Name/Description |
APO-METFORMIN XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack 60 tablets
Batch Number: E16539
Expiry: 12/2019
ARTG: 281210 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility of a small section of white plastic (likely from a cable tie/zip tie) being embedded in any given tablet from this batch. This issue may or may not be visible to users given this contamination is in the form of a segment of white plastic within a large sized white tablet.
The health risk associated with this issue is the possibility of choking or perforation of the GI tract upon consumption.
No related adverse events have been reported to Apotex regarding this matter.
Further information including an image of this defect will be made available on the TGA Website. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pharmacists and consumers are asked to inspect their holdings of APO-Metformin XR 1000mg blister packs immediately and quarantine all units from batch E16539 to prevent further use.
Pharmacist are asked to then complete the supplied Reply Form immediately even if you do not have any affected stock and fax it to Apotex on the number provided to reconcile this process.
Consumers are asked to return affected stock to their Pharmacy for a replacement or refund as allowed under the varying prescription medicine supply laws in each State and Territory.
This action has been closed out on 25/07/2019 |
| Contact Information |
1800 276 839 - Apotex Customer Service: 1 |