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

Published On:

25 January 2023

Published In:

Dr Reddy’s Laboratories (UK) Limited is recalling two batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour.

MDR number

MDR 075-01/23

Company name

Dr Reddy’s Laboratories (UK) Ltd

Product name

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

SNOMED Code

27864411000001103

Batch number Expiry date Pack size First distributed
B2202043 March 2025 28 14 September 2022
B2202044 April 2025 28 14 September 2022

Active Pharmaceutical Ingredients: Lacidipine

Brief description of the 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 for 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 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. Reddy’s Laboratories (UK) Ltd Medical Information Department at 01748 828873, or email [email protected].

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 [email protected].

To read the full article please click HERE

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