HPS Pharmacies wish to advise that Pfizer Australia, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product recall for Clopine® Suspension as follows:
The only affected batches are listed below:
These two batches are being recalled from the market as they have failed stability testing and do not meet the current registered specifications. Affected batches have demonstrated crystal formation over time which adhere to the walls of the bottle and appear throughout the contents. These crystals typically do not re-suspend upon shaking, rendering the product clumpy and not as free-flowing as required. There have not been any reports of adverse effects related to this issue.
An alternative product, Versacloz® 50mg/mL oral suspension, is approved for supply under Section 19A of the Therapeutic Goods Act 1989 until 30th April 2019. Versacloz® is not affected by this recall notice.
Please inspect your stock and quarantine bottles from the affected batches. 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 until supplies return to normal. 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 Pfizer Australia on 1800 999 543.