Type of Product |
Medicine |
TGA Recall Reference |
RC-2015-RN-00260-1 |
Product Name/Description |
Different Brands of Pantoprazole Tablets in Blisters of 30’s.
APO-Pantoprazole
20mg Batch Number (BN): GIX013002 AUST R 213715
40mg. BN: GIY014001, GIY014002, GIY014003, GIY014004, GIY014005, GIY014006 & GIY014007 AUST R 213716
Chemmart Pantoprazole
20mg BN: GIZ013001 AUST R 213717
40mg BN: GJA014001 & GJA014002 AUST R 213718
Terry White Chemists
20mg BN: GIV013001 AUST R 213719
40mg BN: GIW014001 &GIW014002 AUST R 213720 |
Recall Action Level |
Retail |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
17/04/2015 |
Responsible Entity |
|
Reason/Issue |
Apotex Pty Ltd has initiated this recall due to discolouration of the yellow outer film coat layer of tablets over time. The discoloured tablets are light yellow or greenish yellow or brown. The colour of the core tablet is not changed. The mechanism for discolouration is under investigation. While this does not represent any safety or efficacy issue, it may cause customers to be concerned. |
Recall Action |
Recall |
Recall Action Instructions |
Apotex is requesting the retailers to inspect their stock and quarantine all units from the above batch numbers. Apotex is arranging for the stock to be recovered and a credit note issued. This action has been closed-out on 03/03/2016. |
Contact Information |
1800 276 839 - Apotex Customer Service |