Ferring Pharmaceuticals Limited has recalled all unexpired stock of all strengths of desmopressin nasal spray from pharmacies and wholesalers.
The decision to recall the product has taken as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of specification results for the content of the desmopressin acetate (active substance) and benzalkonium chloride (excipient).
The list of products recalled include: Desmospray 0.1 mg/ml Nasal Spray PL 03194/0024, Desmopressin 0.1 mg/ml Nasal Spray PL 03194/0090, and Octim 1.5mg/ml Nasal Spray solution PL 03194/0056.
Desmospray 0.1 mg/ml Nasal Spray PL 03194/0024
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P10427G | 28-Feb-21 | 1×1 | 26-Jun-18 |
| P11704A | 30-Apr-21 | 1×1 | 24-Jul-18 |
| P13215E | 31-May-21 | 1×1 | 26-Sep-18 |
| P13215K | 31-May-21 | 1×1 | 31-Oct-18 |
| P13215N | 31-May-21 | 1×1 | 04-Dec-18 |
| P15231G | 30-Sep-21 | 1×1 | 26-Feb-19 |
| P15231P | 30-Sep-21 | 1×1 | 16-Apr-19 |
| R11847E | 28-Feb-22 | 1×1 | 02-Jul-19 |
| R12217C | 30-Apr-22 | 1×1 | 03-Sep-19 |
| R13643H | 31-Jul-22 | 1×1 | 17-Mar-20 |
| R13643A | 31-Jul-22 | 1×1 | 07-Oct-19 |
| R17389K | 31-Jan-23 | 1×1 | 15-Jun-20 |
| R17389H | 31-Jan-23 | 1×1 | 27-Apr-20 |
| R13643S | 31-Jul-22 | 1×1 | 27-Apr-20 |
Desmopressin 0.1 mg/ml Nasal Spray PL 03194/0090
(Note: Products are packaged with Aspire livery)
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P10427L | 28-Feb-21 | 1×1 | 17-Jul-18 |
| P11704F | 30-Apr-21 | 1×1 | 17-Jul-18 |
| P15231T | 30-Sep-21 | 1×1 | 28-May-19 |
| R11847C | 28-Feb-22 | 1×1 | 17-Jul-19 |
| R13643F | 31-Jul-22 | 1×1 | 20-Jan-20 |
| R13643P | 31-Jul-22 | 1×1 | 20-Apr-20 |
| S11863A | 31-Mar-23 | 1×1 | 29-Jun-20 |
Octim 1.5mg/ml Nasal Spray solution PL 03194/0056
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| N17445E | 31-Dec-20 | 1×1 | 04-Apr-18 |
| P13209F | 30-Apr-21 | 1×1 | 21-Aug-18 |
| P17637A | 31-Dec-21 | 1×1 | 09-Apr-19 |
| R13271G | 30-Apr-22 | 1×1 | 09-Sep-19 |
| R17378A | 31-Dec-22 | 1×1 | 27-Apr-20 |
(Active Pharmaceutical Ingredient: desmopressin acetate).
The pharmacists have been asked to stop supplying the nasal spray batches immediately and quarantine all remaining stock. They could return the stock to their suppliers using the approved process.
For more information or medical information queries, community pharmacies can reach the drug manufacturer through [email protected] or 0800 111 4126.
