The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Notification concerning one batch of Erythromycin Stearate 250mg tablets (Erythrocin®), manufactured by Amdipharm UK Ltd.
There is no risk to product quality, and the batch is not subject to a recall. However, as a precautionary measure, dental teams dispensing or supplying this product are advised to:
- Inform patients that the PIL in the pack may be out of date
- Provide the updated PIL, which can be downloaded from the electronic medicines compendium (eMC)
- Contact the manufacturer for printed copies of the updated leaflet if required.
This alert has been issued due to the inclusion of an outdated Patient Information Leaflet (PIL) in packs from the affected batch. The leaflet does not reflect recent safety updates, including important guidance on medicine interactions and use in pregnancy and breastfeeding.
This notification is particularly relevant where erythromycin may be prescribed as an alternative to penicillin-based antibiotics.
Product details:
- Product: Erythromycin Stearate BP 250mg Tablets (Erythrocin®)
- PL number: 20072/0036
- Batch number: 6104532
- Expiry date: August 2028
- Pack size: 100 tablets
- First distributed: 4 September 2024