HPS Pharmacies wish to advise that Sandoz, in consultation with the Therapeutic Goods Administration (TGA), have given notice of a drug recall of:
Mycophenolate Sandoz® 250mg capsules
The only affected batches are GC9656, GC9647, GC5286, and GC5296.
This recall is in response to the discovery of brown particles during sieving of the active pharmaceutical ingredient (API). Investigations determined that the presence of these particles was confined to one batch of the API. This batch was rejected and not used to manufacture Mycophenolate Sandoz® capsules. No evidence of contamination was observed during the manufacture of subsequent batches that are the subject of this precautionary recall action.
Please inspect your stocks and quarantine all products from the affected batch for a return to your supplier for a refund.
If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect your stock and quarantine all products from the batch stated above for return to the supplier for a refund. Your HPS Pharmacies Pharmacy Manager/Director of Pharmacy will contact your clinicians 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 Sandoz Australia on 1800 726 369.
Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.