Class 2 Medicines Recall: Ennogen Pharma Limited, Trimethoprim 200mg Tablets (PL 40147/0083), EL (21)A/10
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Class | Class 2 |
|---|---|
| Type | Medicines recall/notification |
| Issued | 22 Apr 2021 |
| Reference | EL (21)A/10 |
| Company | Ennogen Pharma Limited |
| Product licences | PL 40147/0083 |
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 qagenerics@ennogen.com.
For stock control queries, please contact Alex Durall and Claire Willey on alex@ennogen.com and claire@ennogen.com.
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.