| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2020-RN-00614-1 |
| Product Name/Description |
MINIRIN (desmopressin acetate) 10 micrograms/actuation Nasal Spray
Batch Numbers: P15231A, R11847L, R12217A, R12217G, R13643C, R17389A.
Expiry Dates: 30/Sep/2020, 28/Feb/2021, 30/Apr/2021, 31/Jul/2021, 31/Jan/2022.
ARTG 59320. |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/07/2020 |
| Responsible Entity |
|
| Reason/Issue |
Ferring Pharmaceuticals is initiating a precautionary recall of all MINIRIN Nasal Spray (desmopressin acetate) batches following the detection of a low volume and out-of-specification results in desmopressin content in some vials.
During testing of a sample from batch R14349, supplied overseas, a nasal spray bottle containing a low volume has been observed and was found as out-of-specification for both desmopressin (up to 155% of the targeted amount) and benzalkonium chloride (up to 120% of the targeted amount) contents. This could potentially result in an overdose of desmopressin.
Ferring has elected to carry out a Class II recall as a precaution. To date, Ferring has not seen an increase in adverse event reports related to complications from over-exposure to desmopressin nasal spray. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pharmacies:
Retail Pharmacies are advised to inspect your stock immediately and quarantine affected stock to prevent further use. Pharmacies are advised to return affected stock on hand using your routine procedure for returning goods to your wholesalers/distributor.
Patients who are currently using MINIRIN Nasal Spray should be instructed to consult their medical practitioner for advice on switching to an alternative desmopressin as MINIRIN Nasal Spray may be out of stock until supply can be reinstated.
Wholesalers/Distributors:
Ferring Australia will contact wholesalers to organise the return of affected goods.
Replacement Stock/Alternatives:
No alternative stock of MINIRIN Nasal Spray is available currently. Alternative formulations are available for patients immediately and are described within the customer letter (supplied by the sponsor to impacted customers). |
| Contact Information |
1800 337 746 - Ferring Australia Customer Service |