Class 3 Medicines Recall: Dr Reddy’s Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets, EL (23)A/03
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].
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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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