Medicines Healthcare Products Regulatory Agency
CLMR Number
CLMR (23)A/06
MDR Number
MDR 007-09/23
Company name
Sun Pharma UK Ltd
Product name
Gemcitabine 10mg/ml Solution for Infusion PL 31750/0062 (Single dose Infusion bag, 2000mg/200ml)
Lot number/expiry
| Product name | Batch number | Expiry date | Pack size | Date first distributed |
|---|---|---|---|---|
| Gemcitabine 10mg/ml Solution for Infusion (Single dose Infusion bag, 2000mg/200ml) | HAE0427A | 01/2025 | 200ml Infusion bag | 10/07/2023 |
Brief Description of Problem
Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion. The affected infusion bags are labelled as 1800mg/180ml rather than 2000mg/200ml (though the secondary packaging is labelled correctly as 2000mg/200ml).
The batch listed above is being recalled as a precautionary measure. This recall is being issued as a company-led recall due to a limited number of units being incorrectly labelled.
Advice for healthcare professionals and wholesalers
- Stop supplying the affected batches immediately. Quarantine all remaining stock and liaise with Sun Pharma UK on the return process.
- Sun Pharma UK has records of all recipients of the affected product and will contact them directly.
Advice for patients
No further action is required by patients, the product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company Contact for medical information enquiries
For medical information enquiries, please contact:
Email: medinfoeurope@sunpharma.com
Tel: 0208 848 5052
Company Contact for stock enquiries
For stock information enquiries, please contact: Sun Pharma UK Customer Services
Email: Cserv.uk@sunpharma.com
Tel: 0208 848 5050