Amitriptyline Hydrochloride 10mg Tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC - 37698206
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Amitriptyline Hydrochloride 10mg Tablets | PL: 43461/0054 | amitriptyline hydrochloride | 5060464502453 |
| Amitriptyline Hydrochloride 25mg Tablets | PL: 43461/0055 | amitriptyline hydrochloride | 5060464502972 |
| Amitriptyline Hydrochloride 50mg Tablets | PL: 43461/0056 | amitriptyline hydrochloride | 5060464502446 |
Batches (expiry): 1404515 (31/12/2025), 1404539 (31/12/2025), 1404540 (31/12/2025), 1404546 (31/12/2025), 1404721 (31/03/2026), 1404722 (31/03/2026), 1404628 (28/02/2026), 1404630 (28/02/2026), 1404631 (28/02/2026), 1404632 (28/02/2026), 1404640 (28/02/2026), 1404641 (28/02/2026), 1404629 (28/02/2026), 1404615 (31/01/2026), 1404616 (31/01/2026), 1404626 (31/01/2026), 1404627 (31/01/2026), 1404724 (31/03/2026), 1404723 (30/04/2026)
Background: 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. The errors were identified following an MHRA Good Pharmacovigilance Practice (GPvP) inspection and further investigation by the Marketing Authorisation Holder, Flamingo Pharma UK Ltd. The missing information from the PIL is detailed in this notification: 2. What you need to know before you take Amitriptyline Hydrochloride tablets