Supply of omeprazole (MAXOR) 20 mg enteric capsule blister pack by Alphapharm Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On December 5 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

(a)   the supply of the product omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994] by Alphapharm Pty Ltd, Royal Exchange Post Office NSW (“the Company”):

That does not conform with the requirements of paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69, in that the prefixes for batch number and expiry date are not included on the blister foil labels.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. This consent applies only to batch 122673, which has an expiry date of April 30 2015.
2. The blister foil label to be used is identical to that provided in correspondence from the Company dated November 20 2012.
3. No other changes have been made to the product omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994], including the carton label.
4. Prior to supply of these batches, the “Dear Pharmacist” letter provided to the TGA in electronic mail dated November 19 2012 will be communicated to pharmacists as planned.