Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34)

Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine.

Product information

PL number

PL 04416/0701

MDR Number

MDR 037-10/19

Company name

Sandoz Limited

Product description

Batch number Expiry Date Pack Size First Distribution
JS1355 31 January 2021 5 vials per carton 21 May 2019

Brief description of the problem

Sandoz Limited is recalling the above batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine. The manufacturer has confirmed the root cause to be an extended exposure to a UV light located within the warehouse and this only affects the batch listed above.

Advice for healthcare professionals

  • Please quarantine all remaining stock of the above batch and return it to your original supplier using your supplier’s approved process.

Company contacts for further information

For enquiries relating to stock returns please contact Sandoz Limited Customer Services on 01276 698607 or email sales.sandoz-gb@sandoz.com

For medical information enquiries, please contact Sandoz Medical Information Team on 01276 698101 or email sandozgb@EU.propharmagroup.com

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 relevant clinics, dispensing general practitioners and community pharmacists.

Download the document

Class 2 Drug Alert, Sandoz Omeprazole 40mg

Published 11 November 2019