HPS Pharmacies wish to give notice that Bayer Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a product recall for Gastrografin® Oral Liquid and Urografin® Injection as follows:
| Product | ARTG | Affected batches |
| Gastrografin® (with star anise oil) | 10684 | MA04JPZ (Exp 30-Apr-2026)
MA04NJF (Exp 30-Nov-2026) |
| Gastrografin® (without star anise oil) | 471827 | MA04T47 (Exp 30-Apr-2029)
MA04T49 (Exp 30-Apr-2029) |
| Urografin® 30% 10mL ampoules | 42161 | MA04F5E (Exp 30-Jun-2026)
MA040FA (Exp 30-Jun-2026) MA047MV (Exp 30-Jun-2026) MA04KBH (Exp 30-Jun-2026) MA04BVS (Exp 30-Nov-2026) MA04S7C (Exp 28-Feb-2030) MA04V62 (Exp 28-Feb-2030) MA04VUM (Exp 28-Feb-2030) |
| Urografin® 30% 250mL bottle | 42163 | MA03X2V (Exp 31-Jul-2026)
MA04MKJ (Exp 28-Feb-2029) MA04MKK (Exp 31-Jul-2029) MA04RNS (Exp 31-Jul-2029) MA04SJ2 (Exp 31-Jul-2029) |
This product recall was initiated following identification of the nitrosamine impurity, N‑Nitroso‑Meglumine (NO-meglumine), at levels exceeding the calculated applicable intake limits.
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. Alternative stock is not currently available. 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 Bayer Australia 1800 633 723, or your pharmacist at HPS Pharmacies.
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