Class 4 Medicines Defect Notification: Ipca Laboratories UK Limited, Various Products, EL(25)A/42
Source: gov.uk (2025-08-26)

Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.

DMRC reference number

DMRC - 35766519

Marketing Authorisation Holder

Ipca Laboratories UK Limited

Medicine Details

Allopurinol 100 mg tablets

PL: 28278/0035

Active ingredient: allopurinol

SNOMED code: 40127111000001108

GTIN: 18901079119732, xx-xxxx-xxxx

Medicine Details

Allopurinol 300 mg tablets

PL: 28278/0036

Active ingredient: allopurinol

SNOMED code: 40127311000001105

GTIN: 18901079119749, xx-xxxx-xxxx

Medicine Details

Amlodipine 5 mg Tablets

PL: 28278/0012

Active ingredient: amlodipine besilate

SNOMED code: 41103211000001109

GTIN: xx-xxxx-xxxx

Medicine Details

Amlodipine 10mg Tablets

PL: 28278/0013

Active ingredient: amlodipine besilate

SNOMED code: 41103411000001108

GTIN: xx-xxxx-xxxx

Medicine Details

Hydroxychloroquine sulfate 200 mg film-coated tablets

PL: 28278/0023

Active ingredient: hydroxychloroquine sulfate

SNOMED code: 38375911000001109

GTIN: 18901079116236, xx-xxxx-xxxx

Medicine Details

Levofloxacin 250mg Film Coated Tablets

PL: 28278/0001

Active ingredient: levofloxacin Hemihydrate

SNOMED code: 39891911000001101

GTIN: xx-xxxx-xxxx

Medicine Details

Levofloxacin 500mg Film Coated Tablets

PL: 28278/0002

Active ingredient: levofloxacin Hemihydrate

SNOMED code: 39892211000001103

GTIN: xx-xxxx-xxxx

Medicine Details

Gabapentin Ipca 100 mg Hard Capsules

PL: 28278/0098

Active ingredient: gabapentin

SNOMED code: Not Available

GTIN: xx-xxxx-xxxx

Medicine Details

Gabapentin Ipca 300 mg Hard Capsules

PL: 28278/0099

Active ingredient: gabapentin

SNOMED code: Not Available

GTIN: xx-xxxx-xxxx

Medicine Details

Gabapentin Ipca 400 mg Hard Capsules

PL: 28278/0100

Active ingredient: gabapentin

SNOMED code: Not Available

GTIN: xx-xxxx-xxxx

Affected lot batch numbers

All current batches

Background

Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information. The errors were identified following a MHRA Good Pharmacovigilance Practice (GPvP) inspection and further investigation by the Marketing Authorisation Holder, Ipca Laboratories UK Ltd. This issue impacts all current batches of the impacted products. Please see the Appendices of the download document for detailed information regarding the missing information in each PIL.

Appendix 1 - Allopurinol 100 mg tablets & Allopurinol 300 mg tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=6)

Appendix 2 - Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=7)

Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=8)

Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=11)

Appendix 5 - Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=13)

Advice for Healthcare Professionals:

Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current PIL. Whilst this information may already be known, this notification provides a reminder of the safety information, which should be considered when prescribing and dispensing these products.

Healthcare professionals involved in dispensing of these products should, where possible, signpost new patients on these medicines to the missing safety information in the PIL. Upon request, Ipca Laboratories UK Ltd will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact xxx@xxx.xx (mailto:xxx@xxx.xx) with your details, i.e. address, product with batch details, required number of leaflets.

The product quality is not impacted. Due to the requirement for these products to support the UK market, the MHRA in discussion with the Department of Health and Social Care (DHSC) consider that batches which are currently packed and available for distribution, will continue to be distributed. Details of the specific batches can be obtained by contacting xxx@xxx.xx (mailto:xxx@xxx.xx) directly.

Ipca Laboratories UK Ltd have confirmed that all new batches produced by the manufacturing site, will be packed with the corrected PILs only and these batches will be available for distribution to UK market from November 2025 onwards.

Advice for Patients:

Patients should continue to take medicines as prescribed by your healthcare professional. The product quality of the impacted batches is not affected, however there is some missing safety information in the Patient Information Leaflet (PIL) that patients should be aware of. Details of the missing safety information can be found in the Appendices related to each individual product.

Appendix 1 - Allopurinol 100 mg tablets & Allopurinol 300 mg tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=6)

Appendix 2 - Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=7)

Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=8)

Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=11)

Appendix 5 - Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf#page=13)

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. (https://yellowcard.mhra.gov.uk/)

Additional information:

For all medical information enquiries and information on this product, please contact via email address:xxx@xxx.xx (mailto:xxx@xxx.xx) or via telephone: xx-xxxx-xxxx

For stock control enquiries please contact via telephone: xx-xxxx-xxxx.

Recipients of this Medicines Notification 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.

Yours faithfully

Defective Medicines Report Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

Download document

Class 4 Medicines Defect Notification, Ipca Laboratories UK Limited, Various Products, EL(25)A/42 (https://assets.publishing.service.gov.uk/media/68a875dd9e1cebdd2c96a108/EL_25_A42_-_Final.pdf)