GovWire

MDR number

MDR 075-01/23

Company name

Dr Reddys Laboratories (UK) Ltd

Product name

Lacidipine 4 mg Film-Coated Tablets, PL 08553/0503

SNOMED Code

27864411000001103

Active Pharmaceutical Ingredients: Lacidipine

Brief description of the problem

Dr Reddys Laboratories (UK) Limited is recalling the above batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour. The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing.

The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated Tablets marketed by Dr Reddys Laboratories (UK) are not affected.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

The recall is a precautionary measure whilst the company completes the investigation. There are no concerns with the medicine and its ability to control blood pressure. Any suspected defective medicine should be reported via the MHRA Yellow Card scheme.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact Dr. Reddys Laboratories (UK) Ltd Medical InformationDepartment at 01748 828873, or email drreddysGB@EU.ProPharmaGroup.com.

For stock control enquiries please contact Dr. Reddys Laboratories (UK) Ltd Customer Services Teamat 01482 389858 (or main switchboard at 01482 860228), or email customerserviceuk@drreddys.com.

Recipients of this Medicines Recall 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 3 Medicines Recall: Dr Reddys Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets, EL (23)A/03