Company led medicines recall: Morphine Syringe 50mg/50ml (unlicensed medicine) and Magnesium Sulphate 8mmol/20ml infusion (unlicensed medicine)
Nova Laboratories Limited (MS 13581) is recalling specific batches of the impacted products due to a potential risk of contamination.
CLMR Number
CLMR (21)A/05
MDR Number
MDR 377-06/21
Company Name
Nova Laboratories Limited (MS 13581)
Product description
Morphine Syringe 50mg/50ml (unlicensed medicine)
Magnesium Sulphate 8mmol/20ml infusion (unlicensed medicine)
Lot Number/Expiry
| Product name | Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|---|
| Morphine Syringe 50mg/50ml | 0015j117 | 13/10/2021 | 50 ml | 24 May 2021 |
| Magnesium Sulphate Infusion 8mmol/20ml | 0002j118 | 05/11/2021 | 50 ml | 7 June 2021 |
Brief Description of Problem
Nova Laboratories Limited (MS 13581) is recalling the above batches of Morphine Syringe 50mg/50ml & Magnesium Sulphate Infusion 8mmol/20ml. The potential risk of contamination was found during validation of the manufacturing process and the batches are being recalled as a precautionary measure
This recall is being issued as a company-led medicines recall, as this product is only supplied to several hospital pharmacies and Nova Laboratories Limited have full traceability of the onward distribution by their customers.
Company Contact for medical information enquiries
For medical information enquiries, please contact: Nova Laboratories Limited by calling 0116 223 0100 or by emailing [email protected].
Company Contact for stock enquiries
For stock information enquiries, Nova Laboratories Limited by emailing [email protected], tel. 0800 975 4840