Drug Recall for Sabril®

HPS Pharmacies wish to give notice that Sanofi-Aventis Australia, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Sabril^® as follows:

Sabril^® Tablets
Vigabatrin 500mg
ARTG 150021

Sabril^® Powder
Vigabatrin 500mg
ARTG 52985

 The only batches affected by this recall are:

• Sabril^® tablets – Batch 2007A (expiry Nov 2025)
• Sabril^® powder – Batch 2028C (expiry Mar 2025)

This drug recall is being undertaken as a precautionary measure following detection of an impurity that is a non-compliance to the product registration.

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.

Availability:

This recall has led to a supply interruption for Sabril^® tablets and powder. Normal supplies of Sabril^® tablets are expected to return in early August 2023; supplies of Sabril^® powder are expected to return by mid-late September 2023.

During this supply interruption, Sanofi has a small amount of the 500mg powder oral sachets  that will remain available for emergency supply for the treatment of infantile spasms (West Syndrome). To request access, please contact Sanofi Medical Information on 1800 818 806.

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 Sanofi-Aventis Australia on 1800 640 791 or your pharmacist at HPS Pharmacies.

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