Amdipharm UK Ltd has issued a Class 4 Medicines Defect Information – Caution in Use.
In relation to: Erythromycin Stearate BP 250mg Tablets (Erythrocin 250 Tablets)
Brief description of the problem
Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL. The superseded PIL used in Batch 6104532 is missing important updated safety information, as per the recommendation from Pharmacovigilance Risk Assessment Committee (PRAC).
Amdipharm UK Ltd has confirmed that 4515 packs of the affected batch are already distributed in the market and 6823 packs are awaiting distribution. Due to supply considerations the remaining packs (6823 units) will continue to be distributed. The updated PIL is available on the website of electronic medicines compendium (eMC).
|
NVS Product Code(s) |
Product Description | Affected Batch No’s | Expiry Date | First Distributed |
| 101576 | ERYTHROCIN STEAR TABS 250MG, PK 100 | 6104532 | 08/2028 | 04/09/2024 |
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batch(es) are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.
What to do next – Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business. The updated PIL is available electronically and can be downloaded from the links within the notification letter.
