Drug Recall for Eribulin Dr. Reddy’s 1 mg/2 mL vials

HPS Pharmacies wish to give notice that Dr. Reddys, in consultation with the Therapeutic Goods Administration (TGA), has issued a drug recall for eribulin vials as follows:

Eribulin Dr. Reddy’s
Eribulin mesylate 1 mg/2 mL
ARTG 390346

The only batch affected by this recall is: H250657 (Expiry: May 2027).

This drug recall was initiated following identification of an out of specification result during stability testing. The assay result reported (93.3 %) is below the registered specification of 95 -100%.

Assay results below the labelled claim may lead to patients receiving a lower-than-intended eribulin dose, potentially resulting in reduced efficacy and subtherapeutic exposure. Dr Reddy’s advises that the probability of adverse health consequences is remote, and no reports of loss of efficacy or of adverse events associated with this problem have been received.

Please inspect your stock and quarantine all products from the affected batch. 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 Dr Reddy’s on 1800 733 397, or your pharmacist at HPS Pharmacies.

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