Print version of this report
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 Apotex Pty Ltd
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