Class 4 Medicines Defect Information: Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery) (Sandoz Limited)
Drug alert number:EL (23)A/38
Date issued: 23 October 2023
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery) (Sandoz Limited)
Company name: Sandoz Limited
Product name: Zinacef 250mg powder for solution for injection or infusion vials, PL 48870/0039
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
Product name: Zinacef 750mg powder for solution for injection or infusion vials, PL 48870/0040
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
Active Pharmaceutical Ingredient: Cefuroxime Sodium
GlaxoSmithKline Ltd
Product name: Zinacef 1.5g powder for solution for injection or infusion vials, PL 00004/0263
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
Product name: Zinacef 250mg powder for solution for injection or infusion vials, PL 00004/0263
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
Product name: Zinacef 750mg powder for solution for injection or infusion vials, PL 00004/0263
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 and retailers
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.
View full alert here.
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
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