Class 2

Class 2 Medicines Recall: Ennogen Pharma Limited, Trimethoprim 200mg Tablets (PL 40147/0083), EL (21)A/10

Ennogen Pharma Limited are recalling an affected batch of Trimethoprim 200mg Tablets as a precautionary measure due to the observation of a foreign tablet, which is identified as Trimethoprim 100mg Tablet.

MDR Number MDR 154-03/21

Company name Ennogen Pharma Limited

Product description Trimethoprim 200mg Tablets

Details of affected batch

Batch Number

Expiry Date

Pack Size

First Distributed

1403288

30/09/2023

14 tablets

21/01/2021

Brief description of problem

Ennogen Pharma Limited are recalling the above batch as a precautionary measure due to the investigation of market complaints. The Marketing Authorisation Holder has received two complaints related to an observation that the sealed container contained a foreign tablet, which following an investigation has been confirmed and identified as Trimethoprim 100mg Tablets (also manufactured by Ennogen Pharma Limited).

Extracts from Patient Information Leaflets:

  • What Trimethoprim Tablets look like and contents of the pack
    • Trimethoprim Tablets 100mg are white, round, flat faced bevelled edge tablet with an approximate diameter of 7.5mm, embossed with ‘T2’ on one side and plain on the other side.
    • Trimethoprim Tablets 200mg are white, round, biconvex tablets with an approximate diameter of 9.0mm, embossed with ‘T & 3’ separated by a score line on one side and plain on the other side. The score line is not intended for breaking the tablet.

Advice to Healthcare Professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process

Company contacts for further information

For more information or medical information queries, please contact Ennogen QA at qagenerics@ennogen.com.

For stock control queries, please contact Alex Durall and Claire Willey on alex@ennogen.com and claire@ennogen.com.

Access the full recall