Product Defect Alert

HPS Pharmacies wish to give notice that Medsurge, in consultation with the Therapeutic Goods Administration (TGA), have issued a product defect alert for Recothrom^® as follows:

Recothrom^® 5000IU Kit
Thrombin (recombinant) 5,000 IU

Recothrom^® is intended for topical use only and should never be administered intravenously. Inadvertent intravenous injection can be fatal.

In August 2020, Baxter updated their packaging to prevent administration errors with Recothrom^®. The new packaging has a “Do Not Inject” sticker applied directly to the transfer syringe. This replaces the older packaging where the warning was fixed to the inside flap of the product carton with instructions for users to place the sticker directly on the transfer syringe. This product defect alert pertains to Recothrom^® product distributed prior to the packaging change.

The affected batches are:

• ZAC1808A, ZAC1810A, ZAC1813A, ZAC1814A, ZAC1815A, ZAC1816A, ZAC1901A, ZAC1908A, ZAC1909A, ZAC1910A, ZAC1911A, ZAC1903A, ZAC1907A, ZAC1907B, and ZAC1917A.

Healthcare professionals are advised that they may continue to use Recothrom^® from the affected batches provided they follow the relevant directions in the product information and only apply the product topically.

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.