Class 4 Medicines Defect Notification: Ipca Laboratories UK Limited, Various Products, EL(25)A/42
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 Number: DMRC - 35766519
Company name:Ipca Laboratories UK Limited
Product description:
- Allopurinol 100 mg tablets
- PL: 28278/0035
- Active ingredient: allopurinol
- SNOMED code: 40127111000001108
- GTIN: 18901079119732, 05060777420482
Product description:
- Allopurinol 300 mg tablets
- PL: 28278/0036
- Active ingredient: allopurinol
- SNOMED code: 40127311000001105
- GTIN: 18901079119749, 05060777420499
Product description:
- Amlodipine 5 mg Tablets
- PL: 28278/0012
- Active ingredient: amlodipine besilate
- SNOMED code: 41103211000001109
- GTIN: 05060777420024
Product description:
- Amlodipine 10mg Tablets
- PL: 28278/0013
- Active ingredient: amlodipine besilate
- SNOMED code: 41103411000001108
- GTIN: 05060777420031
Product description:
- Hydroxychloroquine sulfate 200 mg film-coated tablets
- PL: 28278/0023
- Active ingredient: hydroxychloroquine sulfate
- SNOMED code: 38375911000001109
- GTIN: 18901079116236, 05060777420543
Product description:
- Levofloxacin 250mg Film Coated Tablets
- PL: 28278/0001
- Active ingredient: levofloxacin Hemihydrate
- SNOMED code: 39891911000001101
- GTIN: 05060777420413
Product description:
- Levofloxacin 500mg Film Coated Tablets
- PL: 28278/0002
- Active ingredient: levofloxacin Hemihydrate
- SNOMED code: 39892211000001103
- GTIN: 05060777420437
Product description:
- Gabapentin Ipca 100 mg Hard Capsules
- PL: 28278/0098
- Active ingredient: gabapentin
- SNOMED code: Not Available
- GTIN: 05060777420666
Product description:
- Gabapentin Ipca 300 mg Hard Capsules
- PL: 28278/0099
- Active ingredient: gabapentin
- SNOMED code: Not Available
- GTIN: 05060777420673
Product description:
- 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 information:
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 to 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 to 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.
Company contacts for further 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.
To access the full recall/alert:
Class 4 Medicines Defect Notification, Ipca Laboratories UK Limited, Various Products, EL(25)A/42