Medicines defect noticeMHRA
Zinacef powder for solution defect notice over a labelling error
Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
74 identifiers listed for this notice.
Zinacef powder for solution 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 23K01810
- 23K00020
- 23K00021
- 2004E2
- 2003E2
- 22K01918
- 22K01919
- 23K00019
- 22K00713
- 22K00604
- 2002E2
- 23K02206
- 2003E1
- 2005E1
- 2006E1
- 2007E1
- 2009E1
- 2010E1
- 2011E1
- 2013E1
- 2014E1
- 2001E2
- 2002E1
- 2004E1
- 2008E1
- 2001E1
- Product licenceThe PL number on the carton.
- PL 48870/0039
- PL 48870/0040
- PL 48870/0041
- PL 00004/0263
- ExpiryOn the carton, blister or label.
- 11-2025
- 09-2025
- 03-2025
- 05-2025
- 08-2025
- 06-2025
- 04-2026
- 04-2025
- 02-2024
- 04-2024
- 07-2024
- 10-2024
- 09-2024
- 12-2023
- 12-2024
- 05-2024
- 01-2024
- 03-2024
- First distributedOn the product, its label or its packaging.
- 07/06/2023
- 30/03/2023
- 31/10/2022
- 02/06/2023
- 22/12/2022
- 07/10/2022
- 27/06/2023
- 31/05/2023
- 13/04/2021
- 07/06/2021
- 06/07/2021
- 04/10/2021
- 06/12/2021
- 13/12/2021
- 07/02/2022
- 29/01/2022
- 03/03/2022
- 05/03/2021
- 07/11/2021
- 11/11/2021
- 28/07/2021
- 02/04/2021
- 02/06/2021
- 17/06/2021
- 22/10/2021
- 10/02/2023
What to do now
The issue with Zinacef powder for solution is information: something on the packaging or leaflet is wrong or missing.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(23)A/38). Quoted as issued.
Summary
Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
The risk
MDR number MDR 038-09/23 Company name
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to ensure they aware that Zinacef products reconstituted with aqueous solutions containing up to 1% lidocaine hydrochloride are intended only for intramuscular (IM) use.
If lidocaine is injected intravenously (IV), it may cause cerebral effects such as confusion, changes in vision, numbness, tingling, and vomiting. It can also cause low blood pressure and an irregular heart rate, thereby posing a risk to 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 .
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 .
Open the MHRA notice
Questions
Why has Zinacef powder for solution been recalled?
The issue with Zinacef powder for solution is information: something on the packaging or leaflet is wrong or missing. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.