| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2018-RN-01164-1 |
| Product Name/Description |
Medsurge Calcitriol 1mcg/mL 15mL Oral Solution
Product Code: CAL150
Batch Number: RV1604RB
Expiry: 1 Sept 2019
Batch Number: RV1605RB
Expiry: 1 Oct 2019
NDC Number: 63304-241-59
Supplied under the Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medsurge has been advised of laboratory results that indicate a lower than expected potency for specific batches of Medsurge Calcitriol 1mcg/mL 15mL Oral Solution. Use of these batches would lead to a lower dose administered to patients. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medisurge is requesting customers:-
1. Inspect stocks and quarantine all units of Calcitriol Oral Solution, 1mcg/mL (15mL vial) from the affected batch numbers, then complete the supplied recall stock return form. Complete the Stock Return form even if you have no stock which is subject to recall, as we require this information to reconcile this process; and
2. If any of the recalled stock could have been transferred from your hospital to another, please immediately let the hospital know of the recall. Please retain the Customer Letter in a prominent position for one month in case stock is in transit.
This action has been closed out on 24/02/2020 |
| Contact Information |
1300 788 261 - Medsurge Healthcare |