Product Defect Correction

HPS Pharmacies wish to advise that Apotex, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect correction for Tacrolimus Apotex 0.5mg capsules as follows:

Tacrolimus Apotex Capsules
Tacrolimus 0.5mg
ARTG 209273

The only batch affected by this action is 19122305 with an expiry date of June 2021.

This action has been initiated due to a potential printing anomaly on the foil pouches contained within the cardboard carton. Each carton of Tacrolimus Apotex 0.5mg capsules contains two individually sealed and labelled pouches, with each pouch containing 50 capsules. One or both of these pouches in the affected batch may be incorrectly printed with the 1mg strength, rather than the correct 0.5mg strength. However, all other details, including the pouch contents are correct.

This is a packaging issue only. The quality of the medicine contained within is not affected. Unaffected products from the abovementioned batch may continue to be used as normal.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

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 your pharmacist at HPS Pharmacies, or Apotex on 1800 276 839.

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