| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01367-1 |
| Product Name/Description |
DBL Vancomycin (vancomycin hydrochloride) 500 mg vial
Product code: F000040568
Batch numbers: J036913AA & J036913BA
Expiry date: 06-2023
ARTG 62603
(DBL VANCOMYCIN vancomycin (as hydrochloride) 500mg powder for injection vial) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
Pfizer Australia advises that following an internal investigation, batches of DBL Vancomycin (vancomycin hydrochloride) 500 mg powder for injection vials are being recalled due to out of specification stability results which do not meet the shelf-life specification for potency or have atypically declining potency over the 30-month product shelf-life with analysis predicting product may be at 78% - 87% potency by end of shelf-life. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pfizer asks customers to;
1. Inspect their stock and quarantine all units of DBL™ Vancomycin (vancomycin hydrochloride) 500 mg powder for injection vials with batch numbers mentioned in the customer letter.
2. Return the affected stock to their wholesaler or point of sale for a credit.
3. If any of the recalled stock has been transferred from their hospital to another, please immediately let that hospital know of the urgent recall.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 675 229 - Pfizer Medical Information |