Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.

Please note this is an update to Class 4 Drug Alert Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A10) to include updated batches that are affected for Crescent Pharma Ltd. There are two documents attached, one is the fully updated drug alert containing all impacted batches, including those identified when the drug alert was first issued. The second document contains the newly identified batches only.

MDR Number

MDR 051-09/19

Company Name

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd

Brief description of the problem

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.

The PIL in the above batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen. The leaflet incorrectly states that ‘The maximum daily dose should not exceed 6 [six] tablets (2400 mg).’ This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare prescriber and have been prescribed Ibuprofen 400mg Tablets. The outer carton contains the correct P indications and posology.

Crescent Pharma Ltd products

Ibuprofen 400mg Tablets (Almus Livery) PL 20416/0089

Batch Number Expiry Date Pack Size First Distributed
DO4212N Nov-22 84 19/07/2019  
DO3911N Oct-22 84 19/07/2010  
DO3811N Oct-22 84 12/03/2019  
DO3710N Oct-22 84 12/03/2019  
DO3610N Oct-22 84 18/07/2019  
DO3510N Sep-22 84 11/06/2019  
DO3410N Sep-22 84 11/06/2019  
DO3310N Sep-22 84 07/08/2019  
DO3210N Sep-22 84 11/06/2019  
DO3110N Sep-22 84 16/04/2019  
DO1303N Feb-22 84 08/10/2018  
DO1003N Feb-22 84 12/07/2018  
DO0902N Feb-22 84 12/07/2018  

Ibuprofen 400mg Tablets (Crescent Livery) PL 20416/0089

Batch Number Expiry Date Pack Size First Distributed
DO4312N Dec-22 84 25/11/2019  
DO3010N Sep-22 84 11/12/2019  
DO1705O Apr-23 84 07/10/2019  
DO1605O Apr-23 84 18/10/2019  
DO1505O Apr-23 84 01/10/2019  
DO1405O Apr-23 84 01/10/2019  
DO1305O Apr-23 84 27/12/2019  
DO1205O Apr-23 84 09/09/2019  
DO1104O Apr-23 84 27/12/2019  
DO1004O Mar-23 84 09/09/2019  
DO0904O Mar-23 84 21/11/2019  
DO0804O Mar-23 84 21/11/2019  
DO0703O Mar-23 84 15/11/2019  
DO0603O Feb-23 84 15/11/2019  
DO0503O Feb-23 84 20/01/2020  
DO0403O Feb-23 84 15/11/2019  
DO0101O Dec-22 84 25/11/2019  
001205M Apr-21 84 08/08/2019  

Flamingo Pharma (UK) Ltd products

Ibuprofen 400mg Tablets (Flamingo Pharma Livery) PL 43461/0005

Batch Number Expiry Date Pack Size First Distributed
1402177 Aug-23 24 Oct-18  
1402268 Sep-23 48 Nov-18  
1402278 Oct-23 24 Dec-18  
1402308 Nov-23 84 Dec-18  
1402309 Nov-23 84 Dec-18  
1402310 Nov-23 84 Dec-18  
1402316 Nov-23 84 Jan-19  
1402317 Nov-23 84 Jan-19  
1402318 Dec-23 24 Jan-19  
1402337 Dec-23 48 Jan-19  
1402338 Dec-23 48 Jan-19  
1402363 Dec-23 48 Mar-19  
1402353 Dec-23 48 Mar-19  
1402354 Dec-23 48 Mar-19  
1402352 Dec-23 84 Mar-19  
1402361 Dec-23 84 Mar-19  
1402362 Dec-23 84 Mar-19  
1402368 Jan-24 48 Mar-19  
1402369 Jan-24 24 Mar-19  
1402370 Jan-24 24 Mar-19  
1402424 Mar-24 24 Apr-19  
1402425 Mar-23 48 Apr-19  
1402543 May-24 48 Jul-19  
1402544 May-24 48 Jul-19  
1402554 Jun-24 24 Jul-19  
1402557 Jun-24 84 Aug-19  
1402558 Jun-24 48 Aug-19  
1402559 Jun-24 48 Aug-19  
1402622 Jul-24 48 Sep-19  
1402623 Jul-24 48 Sep-19  
1402624 Jul-24 24 Sep-19  
1402625 Jul-24 24 Sep-19  
1402628 Jul-24 24 Sep-19  
1402670 Aug-24 24 Nov-19  
1402671 Aug-24 24 Nov-19  
1402672 Aug-24 24 Nov-19  
1402673 Aug-24 24 Nov-19  
1402674 Sep-24 48 Nov-19  
1402686 Sep-24 48 Nov-19  
1402687 Sep-24 48 Nov-19  
1402688 Sep-24 48 Nov-19  
1402705 Sep-24 48 Nov-19  
1402706 Sep-24 84 Nov-19  
1402707 Oct-24 48 Dec-19  
1402708 Oct-24 48 Dec-19  
1402709 Oct-24 84 Dec-19  
1402710 Oct-24 84 Dec-19  
1402711 Nov-24 84 Jan-20  
1402837 Dec-24 24 Feb-20  
1402838 Dec-24 24 Feb-20  
1402854 Dec-24 48 Feb-20  
1402839 Dec-24 96 Feb-20  
1402852 Dec-24 96 Feb-20  
1402853 Dec-24 84 Feb-20  

Ibuprofen 400mg Tablets (TEVA Livery) PL 43461/0005

Batch Number Expiry Date Pack Size First Distributed
1402172 Jul-23 84 Sep-18  
1402173 Jul-23 84 Sep-18  
1402174 Aug-23 84 Oct-18  
1402175 Aug-23 84 Oct-18  
1402176 Aug-23 84 Oct-18  
1402178 Aug-23 84 Oct-18  
1402279 Nov-23 84 Dec-18  

Advice for healthcare professionals

When dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.

Correct statement: The maximum daily dose should not be more than 3 tablets (1200 mg).

Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.

Further Information

Crescent Pharma Ltd.

Updated PIL information

For more information or medical information queries, please contact Crescent Pharma Ltd. Medical Information Department on
+00351 214643225 01256 772740 tiago.barca@pharsolution.com

Flamingo Pharma (UK) Ltd.

For more information or medical information queries, please contact Flamingo Pharma (UK) Ltd on 07733 522465

Download document

Class 4 Drug Alert Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A10)

Class 4 Drug Alert Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A10) - Updates

Updates to this page

Published 20 February 2020
Last updated 24 February 2020 + show all updates
  1. Please note this is an update to EL(20)A) to include updated batches that are affected for Crescent Pharma Ltd. There are two documents attached, one is the fully updated drug alert containing all impacted batches, including those identified when the drug alert was first issued. The second document contains the newly identified batches only.

  2. First published.