Recall of Celestone® Chronodose® Injection Ampoule

HPS Pharmacies wish to give notice that Organon Pharma, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Celestone^® Chronodose^® Injection Ampoule as follows:

Celestone^® Chronodose^® Injection Ampoule
Betamethasone (as acetate and sodium phosphate) 5.7 mg/mL
ARTG 18777

This recall has been initiated due to the potential for ampoules in the affected batches to contain stainless steel particles, arising from the manufacturing process. The size of the particles identified in the investigation are within range or smaller than the needle diameter recommended for administering the product. Therefore, there is a risk of the stainless steel particles being injected into a patient.

Potential adverse effects associated with this could include:

• Foreign body granuloma (local inflammatory reaction); and
• New-onset or worsening joint inflammation (for intra-articular doses).

Affected batches are: W001995, W005320, W010769 and W015061

Please inspect your stock and quarantine all products 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 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 Organon Pharma on 1800 024 874 or your pharmacist at HPS Pharmacies.

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