| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2018-RN-00641-1 |
| Product Name/Description |
DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bag
All Batches
ARTG Number: 129476 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
In February 2018, a customer reported that a single unit of DBL METRONIDAZOLE INTRAVENOUS INFUSION INJECTION metronidazole 500mg/100mL (from a 10 unit box) showed visible black particles reported as mould between the infusion bag (primary packaging) and plastic overwrap (secondary packaging).
The unlikely growth of mould between the primary bag and secondary bag is considered a direct result of the primary bag slowly leaking over time and the accumulation of the leaked solution in the non-sterile secondary overwrap bag.
Further evaluation of the primary bag confirmed that the leak is the result of pre-existing damage to the polycarbonate stopper, which is supplied by a third party.
The overall incidence of this defect is considered as low. |
| Recall Action |
Recall |
| Recall Action Instructions |
All DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bags require a manual squeeze test to check for the presence of leaks in the primary container after removal of secondary overwrap packaging.
If any visible moisture, liquid or mould is detected either before or after removal of the primary bag from the overwrap, in DBL METRONIDAZOLE INTRAVENOUS INFUSION metronidazole 500mg/100mL solution for injection bags, please discard the product and report the incident to Pfizer Medical information on 1800 675 229.
Please ensure relevant staff members are informed of this product defect alert, including locums and relevant clinicians who may decide to monitor for adverse events.
This action has been closed out on 26/08/2019 |
| Contact Information |
1800 675 229 - Pfizer Medical Information |