Class 3 Medicines Recall: Dr Reddy’s Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets, EL (23)A/03
MDR Number: MDR 075-01/23
Company name: Dr Reddy’s Laboratories (UK) Ltd
Product description: Lacidipine 4 mg Film-Coated Tablets, PL 08553/0503
Details of the affected batches:
|
Batch number |
Expiry date |
Pack size
|
First distributed |
|
B2202043 |
March 2025 |
28 |
14 September 2022 |
|
B2202044 |
April 2025 |
28 |
14 September 2022 |
Brief description of problem:
Dr Reddy’s 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 Reddy’s Laboratories (UK) are not affected.
Advice to Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to 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.
Company contacts for further information:
For medical information enquiries please contact Dr. Reddy’s Laboratories (UK) Ltd Medical Information Department at 01748 828873, or email drreddysGB@EU.ProPharmaGroup.com.
For stock control enquiries please contact Dr. Reddy’s Laboratories (UK) Ltd Customer Services Team at 01482 389858 (or main switchboard at 01482 860228), or email customerserviceuk@drreddys.com.
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