Class 4 MHRA Drug Alert – Prednisolone 5mg Tablets (Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)) Caution in use

Class 4 MHRA Drug Alert – Prednisolone 5mg Tablets (Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)) Caution in use

April 26, 2019

Drug Alert No: EL (19) A/11
Date Issued: 26th April 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Prednisolone 5mg Tablets Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)

Prednisolone 5mg Tablets Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)

PL 42967/0037

Batch Number Expiry Date Pack Size First Distributed
1809653 08/2021 1 x 28 28/01/2019
1809654 08/2021 1 x 28 28/01/2019
1809655 08/2021 1 x 28 30/01/2019
1809656 08/2021 1 x 28 06/02/2019
1809657 08/2021 1 x 28 26/02/2019

Genesis Pharmaceuticals Ltd has informed MHRA that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all packaging.

Advice for community pharmacy teams:

There is a risk to patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength. Packs from the above distributor with the above batch numbers should not be dispensed to patients who rely solely on Braille. MHRA understands that alternative batches of the product are available from a number of suppliers.

View the full alert here

For further information, please contact Genesis Pharmaceuticals Ltd, tel. 020 7201 0400



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