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 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.
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
Last updated 24 February 2020 + show all updates
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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.
-
First published.