Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API)

Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level

MDR number

MDR 38-02/17

Brief description of the problem

MHRA has recently been made aware that some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) used to manufacture the above finished products may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Batches of API produced between the second half of 2014 and June 2017 are potentially affected. A recall is not considered appropriate at this stage.

Product information

Marketing Authorisation Holder Product PL Number
B Braun Melsungen AG Gentamicin 1mg/ml Solution for Infusion 03551/0116
B Braun Melsungen AG Gentamicin 3mg/ml Solution for Infusion 03551/0117
Sanofi Cidomycin (Gentamicin) 80mg/2ml Solution for Injection 04425/0672
Hospira UK Limited Gentamicin40mg/ml Injection 04515/0037
Zentiva Gentamicin Intrathecal 5mg/ml Solution for Injection 17780/0506
Zentiva Gentamicin Paediatric 20mg/2ml Solution for Injection 17780/0507
Amdipharm UK Limited Gentamicin 40mg/ml Solution for Injection 20072/0056
Wockhardt UK Limited Gentamicin 10mg/ml Solution for Injection or Infusion 29831/0659
Wockhardt UK Limited Gentamicin 40mg/ml Solution for Injection or Infusion 29831/0660

Additional information

Healthcare Professionals are advised to be cautious when using the above products. In particular, caution should be taken when using gentamicin concomitantly with drugs known to cause histamine release (for example opioids and muscle relaxants).

Patients should be monitored closely for potential adverse reactions associated with increased levels of histamine, which may cause anaphylactoid (for example flushing, itching, urticaria and shortness of breath) or hypotensive reactions and increased heart rate. In particular, heart rate and blood pressure should be monitored throughout administration. Paediatric patients and patients with severe renal impairment may be more susceptible to the effects of exogenous histamine, therefore these patients should be monitored more closely. Any suspected ADRs observed should be reported to the relevant Marketing Authorisation Holder and to MHRA on a Yellow Card.

Contact information

B. Braun Melsungen AG
Mrs Catherine Clulow,
Team Leader Quality
Tel: 0114 2259155

Sanofi and Zentiva
Sanofi Medical Information Department
Tel: 0845 3727101

Email: UK-Medicalinformation@sanofi.com

Hospira UK Limited
Pfizer Medical Information
Tel: 01304 616161

Email: Medical.Information@pfizer.com

Amdipharm UK Limited
Stock: Concordia Customer Care
Tel: 08708 877025

Email: customercare@concordiarx.com

Amdipharm UK Limited
Medical Information:
Tel: 08700 703033

Email: medicalinformation@concordiarx.com

Wockhardt UK Limited
Medical Information
Tel: 01978 661261

Email: drug.safety@wockhardt.co.uk

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Class 4 medicines defect information

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, relevant clinics and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.

Published 17 October 2017