Bisoprolol Fumarate 1.25mg, 2.5mg, 3.75mg, 5mg, 10mg Tablets, PA0688/014/001-005, Batch Recall
We wish to advise you that the below-listed batches of Bisoprolol Fumarate Tablets are being recalled with immediate effect.
This recall is going to pharmacy level.
The recall is due to levels of a nitrosamine impurity above the acceptable limit.
The recall letters can be downloaded in the Documents section at the bottom of this webpage.
Product information
- Product name
-
Bisoprolol Fumarate 1.25mg Tablets
Bisoprolol Fumarate 2.5mg Tablets
Bisoprolol Fumarate 3.75mg Tablets
Bisoprolol Fumarate 5mg Tablets
Bisoprolol Fumarate 10mg Tablets - Authorisation holder
- Chanelle Medical Unlimited Company
- Authorisation number
-
PA0688/014/001,
PA0688/014/002,
PA0688/014/003,
PA0688/014/004,
PA0688/014/005,
- Serial or batch number and expiry date
- See table below in the Reference section of this webpage.
- Human or veterinary medicine
- Human
- Target audience
- Wholesalers and pharmacies
- Recall level
- Pharmacy level
Actions to be taken
Information for Pharmacists
Pharmacists are requested to perform the following actions:
Immediately identify and quarantine any units of the below batches in your pharmacy. For hospital pharmacists, this includes stock on wards, in clinics and at any other relevant locations within your hospital.
Return quarantined units to your supplier, indicating that they are being returned as a result of this recall action.
If you have supplied units of these batches to any other pharmacy, clinic or other such establishment, please forward a copy of the recall letter to them, and request they quarantine and return any unused units to you.
Information for Patients/Public
No action is required at user level. If you have this medication in your possession and have any queries, please contact your pharmacist.
Reference
| Product | PA Number | Batch Number | Expiry Date |
| Bisoprolol Fumarate 1.25mg Tablets | PA0688/014/001 | 29735M/2 | 10 2025 |
| Bisoprolol Fumarate 1.25mg Tablets | PA0688/014/001 | 29735M/3 | 10 2025 |
| Bisoprolol Fumarate 1.25mg Tablets | PA0688/014/001 | 30830M/1 | 10 2026 |
| Bisoprolol Fumarate 2.5mg Tablets | PA0688/014/002 | 30711K/1 | 09 2026 |
| Bisoprolol Fumarate 2.5mg Tablets | PA0688/014/002 | 29709M/4 | 10 2025 |
| Bisoprolol Fumarate 2.5mg Tablets | PA0688/014/002 | 30725K/1 | 09 2026 |
| Bisoprolol Fumarate 3.75mg Tablets | PA0688/014/003 | 30800L/1 | 10 2026 |
| Bisoprolol Fumarate 5mg Tablets | PA0688/014/004 | 30678K/1 | 08 2026 |
| Bisoprolol Fumarate 5mg Tablets | PA0688/014/004 | 31085A/2 | 01 2027 |
| Bisoprolol Fumarate 5mg Tablets | PA0688/014/004 | 31160B/1 | 01 2027 |
| Bisoprolol Fumarate 10mg Tablets | PA0688/014/005 | 31006A/2 | 12 2026 |
| Bisoprolol Fumarate 10mg Tablets | PA0688/014/005 | 30874M/3 | 10 2026 |
| Bisoprolol Fumarate 10mg Tablets | PA0688/014/005 | 30874M/2 | 10 2026 |
| Bisoprolol Fumarate 10mg Tablets | PA0688/014/005 | 30634J/1 | 08 2026 |