Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, El(25)a/52
Recall Summary Flamingo Pharma UK Ltd's Amitriptyline Hydrochloride tablets (10mg, 25mg, and 50mg) are being recalled in the United Kingdom because the patient information leaflets included with these products are missing some required safety information. This affects patients in the UK who have these medications. The recall is classified as Class III, indicating a potential health risk.
- Recalling firm
- Flamingo Pharma UK Ltd
- Reason
- Flamingo Pharma 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.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-12-10
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/aaad35ff-3b2f-40b2-b325-eb8726303d04