Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29
Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers 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).
MDR Number
MDR 075-07/20
Company name
Ferring Pharmaceuticals Limited
Product description
Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P10427G | 28-Feb-21 | 1x1 | 26-Jun-18 |
| P11704A | 30-Apr-21 | 1x1 | 24-Jul-18 |
| P13215E | 31-May-21 | 1x1 | 26-Sep-18 |
| P13215K | 31-May-21 | 1x1 | 31-Oct-18 |
| P13215N | 31-May-21 | 1x1 | 04-Dec-18 |
| P15231G | 30-Sep-21 | 1x1 | 26-Feb-19 |
| P15231P | 30-Sep-21 | 1x1 | 16-Apr-19 |
| R11847E | 28-Feb-22 | 1x1 | 02-Jul-19 |
| R12217C | 30-Apr-22 | 1x1 | 03-Sep-19 |
| R13643H | 31-Jul-22 | 1x1 | 17-Mar-20 |
| R13643A | 31-Jul-22 | 1x1 | 07-Oct-19 |
| R17389K | 31-Jan-23 | 1x1 | 15-Jun-20 |
| R17389H | 31-Jan-23 | 1x1 | 27-Apr-20 |
| R13643S | 31-Jul-22 | 1x1 | 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 | 1x1 | 17-Jul-18 |
| P11704F | 30-Apr-21 | 1x1 | 17-Jul-18 |
| P15231T | 30-Sep-21 | 1x1 | 28-May-19 |
| R11847C | 28-Feb-22 | 1x1 | 17-Jul-19 |
| R13643F | 31-Jul-22 | 1x1 | 20-Jan-20 |
| R13643P | 31-Jul-22 | 1x1 | 20-Apr-20 |
| S11863A | 31-Mar-23 | 1x1 | 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 | 1x1 | 04-Apr-18 |
| P13209F | 30-Apr-21 | 1x1 | 21-Aug-18 |
| P17637A | 31-Dec-21 | 1x1 | 09-Apr-19 |
| R13271G | 30-Apr-22 | 1x1 | 09-Sep-19 |
| R17378A | 31-Dec-22 | 1x1 | 27-Apr-20 |
Active Pharmaceutical Ingredient: desmopressin acetate
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return these to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact
Email: Medical.UK@Ferring.com
Tel: 0800 111 4126
For stock control queries, please contact
Email: Customer.Services@Ferring.com
Tel: 0800 111 4125
For Aspire livery stock (Desmopressin 0.1 mg/ml Nasal Spray, PL 03194/0090), please contact
Email: customerservices@aspirepharma.co.uk
Tel: 01730 231148
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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