Class 4 Medicines Defect Information: Zinacef powder for solution for injection or infusion vials (Sandoz Limited)

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

Product name: Zinacef 750mg powder for solution for injection or infusion vials, PL 48870/0040

Active Pharmaceutical Ingredient:  Cefuroxime Sodium

GlaxoSmithKline Ltd

Product name: Zinacef 1.5g powder for solution for injection or infusion vials, PL 00004/0263

Product name: Zinacef 250mg powder for solution for injection or infusion vials, PL 00004/0263

Product name: Zinacef 750mg powder for solution for injection or infusion vials, PL 00004/0263

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:

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