Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38
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.
MDR number
MDR 038-09/23
Company name
Sandoz Limited
Zinacef 250mg powder for solution for injection or infusion vials, PL 48870/0039
SNOMED Code
4740211000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 23K01810 | 11-2025 | 1 | 07/06/2023 |
| 23K00020 | 09-2025 | 1 | 30/03/2023 |
| 23K00021 | 09-2025 | 1 | 30/03/2023 |
| 2004E2 | 03-2025 | 1 | 31/10/2022 |
| 2003E2 | 05-2025 | 1 | 31/10/2022 |
Zinacef 750mg powder for solution for injection or infusion vials, PL 48870/0040
SNOMED Code
3939311000001103
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 22K01918 | 08-2025 | 1 | 02/06/2023 |
| 22K01919 | 09-2025 | 1 | 02/06/2023 |
| 23K00019 | 09-2025 | 1 | 02/06/2023 |
| 22K00713 | 08-2025 | 1 | 22/12/2022 |
| 22K00604 | 08-2025 | 1 | 22/12/2022 |
| 2002E2 | 06-2025 | 1 | 07/10/2022 |
Zinacef 1.5g powder for solution for injection or infusion vials, PL 48870/0041
SNOMED Code
4530311000001103
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 23K02206 | 04-2026 | 1 | 27/06/2023 |
| 2002E2 | 04-2025 | 1 | 31/05/2023 |
Active Pharmaceutical Ingredient: Cefuroxime Sodium
GlaxoSmithKline Ltd
Zinacef 1.5g powder for solution for injection or infusion vials, PL 00004/0263
SNOMED Code
4530311000001103
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2003E1 | 02-2024 | 1 | 13/04/2021 |
| 2005E1 | 02-2024 | 1 | 07/06/2021 |
| 2006E1 | 04-2024 | 1 | 06/07/2021 |
| 2007E1 | 04-2024 | 1 | 04/10/2021 |
| 2009E1 | 07-2024 | 1 | 04/10/2021 |
| 2010E1 | 07-2024 | 1 | 06/12/2021 |
| 2011E1 | 10-2024 | 1 | 06/12/2021 |
| 2013E1 | 10-2024 | 1 | 13/12/2021 |
| 2014E1 | 10-2024 | 1 | 07/02/2022 |
Zinacef 250mg powder for solution for injection or infusion vials, PL 00004/0263
SNOMED Code
4740211000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2001E2 | 10-2024 | 1 | 29/01/2022 |
| 2005E1 | 09-2024 | 1 | 03/03/2022 |
| 2002E1 | 12-2023 | 1 | 05/03/2021 |
| 2004E1 | 07-2024 | 1 | 07/11/2021 |
| 2003E1 | 07-2024 | 1 | 11/11/2021 |
Zinacef 750mg powder for solution for injection or infusion vials, PL 00004/0263
SNOMED Code
3939311000001103
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 2008E1 | 07-2024 | 1 | 07/11/2021 |
| 2001E2 | 12-2024 | 1 | 03/03/2022 |
| 2009E1 | 10-2024 | 1 | 03/03/2022 |
| 2005E1 | 05-2024 | 1 | 28/07/2021 |
| 2002E1 | 01-2024 | 1 | 02/04/2021 |
| 2003E1 | 03-2024 | 1 | 02/06/2021 |
| 2004E1 | 04-2024 | 1 | 17/06/2021 |
| 2006E1 | 07-2024 | 1 | 22/10/2021 |
| 2001E1 | 12-2023 | 1 | 10/02/2023 |
Active Pharmaceutical Ingredient: Cefuroxime Sodium
Brief description of the problem
Sandoz, the Marketing Authorisation Holder (MAH), has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime offer possibility for both intramuscular (IM) and intravenous (IV) administration. The PIL and SmPC state that cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. However, dilution with lidocaine is intended only for intramuscular (IM) use. As this is not explicitly mentioned, the MAH considers this to pose a potential for medication errors.
The current instructions within the PIL and SmPC, and the corrected instructions (for future PILs and SmPCs) are detailed below:
| Current instructions within PIL and SmPC | Corrected instructions (changes underlined) |
|---|---|
| Instructions for reconstitution Compatibility 1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL). 1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL). Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be used. Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. |
Instructions for reconstitution Compatibility 1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL). 1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL). Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be used for intravenous use only.. Zinacef 250 mg, 750 and 1.5 g powder for solution for injection or infusion (intramuscular use only). Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride for intramuscular use. |
The MAH would like to make clear that reconstitution with aqueous solutions containing up to 1% lidocaine hydrochloride is intended only for intramuscular (IM) use.
Note: This problem impacts Zinacef batches marketed by the current Marketing Authorisation Holder, Sandoz Ltd, and the former Marketing Authorisation Holder GlaxoSmithKline Ltd.
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.
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.
Further Information
For more information, medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101. For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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