Source: MHRA/Gov.uk 26.8.2025
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, 05060777420482
Medicine Details
Allopurinol 300 mg tablets
PL: 28278/0036
Active ingredient: allopurinol
SNOMED code: 40127311000001105
GTIN: 18901079119749, 05060777420499
Medicine Details
Amlodipine 5 mg Tablets
PL: 28278/0012
Active ingredient: amlodipine besilate
SNOMED code: 41103211000001109
GTIN: 05060777420024
Medicine Details
Amlodipine 10mg Tablets
PL: 28278/0013
Active ingredient: amlodipine besilate
SNOMED code: 41103411000001108
GTIN: 05060777420031
Medicine Details
Hydroxychloroquine sulfate 200 mg film-coated tablets
PL: 28278/0023
Active ingredient: hydroxychloroquine sulfate
SNOMED code: 38375911000001109
GTIN: 18901079116236, 05060777420543
Medicine Details
Levofloxacin 250mg Film Coated Tablets
PL: 28278/0001
Active ingredient: levofloxacin Hemihydrate
SNOMED code: 39891911000001101
GTIN: 05060777420413
Medicine Details
Levofloxacin 500mg Film Coated Tablets
PL: 28278/0002
Active ingredient: levofloxacin Hemihydrate
SNOMED code: 39892211000001103
GTIN: 05060777420437
Medicine Details
Gabapentin Ipca 100 mg Hard Capsules
PL: 28278/0098
Active ingredient: gabapentin
SNOMED code: Not Available
GTIN: 05060777420666
Medicine Details
Gabapentin Ipca 300 mg Hard Capsules
PL: 28278/0099
Active ingredient: gabapentin
SNOMED code: Not Available
GTIN: 05060777420673
Medicine Details
Gabapentin Ipca 400 mg Hard Capsules
PL: 28278/0100
Active ingredient: gabapentin
SNOMED code: Not Available
GTIN: 05060777420680
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
- Appendix 2 – Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets
- Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets
- Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets
- Appendix 5 – Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules
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 quality@ipcauk.com 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 quality@ipcauk.com 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
Appendix 2 – Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets
Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets
Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets
Appendix 5 – Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules
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.
Additional information:
For all medical information enquiries and information on this product, please contact via email address:pharmacovigilance@ipcauk.com or via telephone: 08003685328
For stock control enquiries please contact via telephone: +44 (0)7446 189 936.
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 Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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