The Natural Choice for Bespoke Healthcare Compliance

The Natural Choice for Bespoke Health and Social Care Compliance

MANAGING SICKNESS ABSENCE | strategies for compliance and wellbeing in health and social care

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

Published On:

22 April 2021

Published In:

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.

Product Information

PL Number

PL 40147/0083

MDR Number

MDR 154-03/21

Product description

Trimethoprim 200mg Tablets

  • Batch number: 1403288
  • Expiry Date: 30/09/2023
  • Pack size: 14 tablets
  • First distributed: 21/01/2021

Active Pharmaceutical Ingredient: trimethoprim

Brief description of the 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 for healthcare professionals

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

Further Information

For more information or medical information queries, please contact Ennogen QA at [email protected].

For stock control queries, please contact Alex Durall and Claire Willey on [email protected] and [email protected].

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Download document

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

 

To read the full article please click HERE

Request a Callback with Our Specialist Team!

Leave your contact details along with a few lines about the nature of your enquiry and a specialist member of our team will get in touch.

This website uses cookies to ensure you get the best experience on our website. Learn more

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors