Class 4 Medicines Defect Information:

Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets) (Flamingo Pharma UK Ltd)

Drug alert number: EL (22)A/43

Date issued: 12 October 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Ibuprofen 400mg Tablets, PL 43461/0005

Batch Number
Expiry Date
Pack Size
First Distributed
20169
02/2027
48s
09 Jun 2022
20170
02/2027
48s
09 Jun 2022
20171
02/2027
84s
09 Jun 2022
20172
02/2027
84s
09 Jun 2022
20176
02/2027
84s
09 Jun 2022
20177
02/2027
96s
15 Jun 2022
20178
02/2027
96s
15 Jun 2022
20179
02/2027
24s
15 Jun 2022
20236
03/2027
84s
04 Jul 2022
20237
03/2027
84s
04 Jul 2022
20238
03/2027
84s
04 Jul 2022
20239
03/2027
84s
04 Jul 2022
20240
03/2027
84s
04 Jul 2022
20241
03/2027
84s
04 Jul 2022
20242
03/2027
24s
15 Jul 2022
20243
04/2027
24s
15 Jul 2022
20251
04/2027
48s
21 Jul 2022
20252
04/2027
48s
21 Jul 2022
20262
04/2027
84s
21 Jul 2022
20263
04/2027
84s
21 Jul 2022
20277
04/2027
24s
15 Jul 2022
20278
04/2027
48s
15 Jul 2022
20265
04/2027
84s
15 Jul 2022
20266
04/2027
84s
15 Jul 2022
20264
04/2027
84s
15 Jul 2022
20279
04/2027
48s
17 Aug 2022
20303
05/2027
84s
17 Aug 2022
20304
05/2027
84s
17 Aug 2022
20305
05/2027
48s
17 Aug 2022
20306
05/2027
48s
17 Aug 2022
20307
05/2027
48s
17 Aug 2022
20314
05/2027
48s
17 Aug 2022
20315
05/2027
48s
17 Aug 2022
20316
05/2027
24s
17 Aug 2022
20317
05/2027
24s
17 Aug 2022
20318
05/2027
24s
25 Aug 2022
20322
05/2027
24s
25 Aug 2022
20323
05/2027
24s
30 Aug 2022
20329
05/2027
84s
25 Aug 2022
20355
06/2027
84s
23 Sep 2022
20356
06/2027
84s
20 Sep 2022
20357
06/2027
84s
20 Sep 2022
20358
06/2027
84s
20 Sep 2022
20359
06/2027
84s
20 Sep 2022
20360
06/2027
84s
21 Sep 2022
20361
06/2027
84s
21 Sep 2022
20362
06/2027
84s
22 Sep 2022

Active Pharmaceutical Ingredient: Ibuprofen

Paracetamol 500mg Tablets (Caplets), PL 43461/0078

Batch Number
Expiry Date
Pack Size
First Distributed
20103
12/26
16s
25 Aug 2022
20112
12/26
16s
25 Aug 2022
20257
04/27
16s
30 Aug 2022
20258
04/27
16s
30 Aug 2022
20259
04/27
16s
25 Aug 2022
20260
04/27
16s
25 Aug 2022
20261
04/27
16s
25 Aug 2022
20337
05/27
16s
25 Aug 2022
20338
05/27
16s
06 Sep 2022
20339
05/27
16s
06 Sep 2022
20340
06/27
16s
06 Sep 2022
20341
06/27
16s
06 Sep 2022

Active Pharmaceutical Ingredient: Paracetamol

Brief description of the problem

Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg tablets. The batches where this defect has been confirmed are batches 20242, 20277 and 20316. The batch number and expiry date are either missing on the carton or the printing is misaligned, which may affect readability. The batch numbers and expiry dates on the blisters within the cartons are clear and present, therefore these impacted batches are not being recalled at this stage. In addition to the three batches of the ibuprofen product affected (20242, 20277, and 20316), Flamingo Pharma UK Ltd cannot exclude that the other batches of paracetamol and ibuprofen are potentially impacted by this issue.

Flamingo Pharma UK Ltd has confirmed that the quality and safety of the product is not impacted, and the batch numbers and expiry dates on the blisters within the cartons are clear and present.

Advice for healthcare professionals 

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled. Healthcare professionals should check the outer carton before dispensing the affected products to ensure the batch number and expiry is present and can be read. In the event of a future recall or medical enquiry, the batch number on the blister should be referred to if the number on the carton cannot be read.

A small proportion of these packs have been overlabelled by Mawdsley Brooks & Co Ltd and they have confirmed they will contact customers directly to inform them of this issue.

Additionally, some batches of Paracetamol 500mg tablets (caplets) have been distributed to retail stores. Staff there are conducting visual checks of the outer carton to ensure that only packs with batch numbers and expiry dates present are available for consumers/patients to purchase.

Advice for patients

Patients should note the information relating to missing batch numbers and expiry dates on some packs of Ibuprofen 400mg Tablets marketed by Flamingo Pharma UK Ltd, and the potential for other batches of Ibuprofen 400mg Tablets and Paracetamol 500mg tablets (caplets) to be impacted. There are no concerns about the safety or quality of the medicine. If you find a carton with no batch number or expiry date, please refer to the blister for the correct batch number and expiry date. If you have any additional concerns, please inform your healthcare professional.

View full alert here.

For further information please contact:

Flamingo Pharma

For medical information safety@flamingopharma.co.uk or general product enquiry sales@flamingopharma.co.uk +44 (0) 7733522465

Or

Mawdsley Brooks & Co Ltd

Overlabellingcustomerservices@mawdsleys.co.uk 01302 553064

The post MHRA Class 4 Medicines Defect Information: Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets) (Flamingo Pharma UK Ltd) appeared first on PSNC Website.