Class 2 Medicines Recall Omeprazole 40mg powder for solution for infusion (Sandoz)

Class 2 Medicines Recall Omeprazole 40mg powder for solution for infusion (Sandoz)

November 11, 2019

Drug Alert No: EL (19) A/34

Date issued 11th November 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Omeprazole 40mg powder for solution for infusion (Sandoz) PL 044416/0701

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

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.

The full drug alert can be viewed here. 

Company contacts for further information
For stock returns enquiries contact Sandoz Limited Customer Services on: 01276 698607 or email sales.sandoz-gb@sandoz.com

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



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