Product Appearance Issue

HPS Pharmacies wish to give notice that Amdipharm Mercury, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a minor discrepancy in the appearance of Tofranil^® tablets as follows:

Tofranil^® Tablets
Imipramine 25mg
ARTG 60673

Tofranil^® has been unavailable since mid-2020. However, new batches are expected to be released soon. Technical issues relating to printing on the sugar-coated tablets were encountered. This has resulted in poor legibility of the printed letters “CZ” on the tablet surface.

Investigations demonstrate that this issue does not directly influence patient safety or the efficacy of the product. Healthcare professionals are encouraged to advise patients of this defect prior to supply and reassure them that the product is safe and effective to consume.

All batches affected by this issue have an expiry date of 30^th November 2023. Affected batch numbers are:

• 6440706
• 6440707
• 6440709
• 6440710

Retain this notice in a prominent position, including in other related business units, for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Amdipharma Mercury on 1800 627 680, or your pharmacist at HPS Pharmacies.