Recall of Abstral®

HPS Pharmacies wish to advise that Menarini, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall for Abstral^® 100mcg sublingual tablets as follows:

Abstral^® Sublingual Tablets
Fentanyl 100mcg
ARTG 193332

The only batch affected by this action is 608895801 (pack size 10) with an expiry date of August 2021.

Please note: the batch number printed on the blister strips is 6088958.

This action has been initiated following one confirmed report of two tablets missing from a blister strip. This anomaly presents a potential risk of a patient missing a dose of Abstral^®. This is a potential packaging issue only; there are no quality or efficacy concerns with the tablets themselves.

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 Menarini on 1800 644 542, or your pharmacist at HPS Pharmacies.