Safety Alerts & Recalls
What does this mean?
This recall for Gabapentin 100mg capsules from Ranbaxy (UK) Limited was issued at the wholesale and pharmacy level only. The MHRA and company involved have determined that there is no specific evidence to suggest that the medicines are not safe for patient use. People who have this medicine should continue to take their medicine as directed. If you take gabapentin and are concerned, you should follow up with your doctor or pharmacist.
If you are experiencing suicidal thoughts and/or behaviours, the following suicide hotline is available in the UK to help you: 08457 90 90 90 or http://www.samaritans.org/
Pharmacy Level Recall of Gabapentin 100mg Capsules: Safety Warnings Missing From Patient Information Leaflet
Ranbaxy (UK) Limited is recalling unused stock of Gabapentin 100mg capsules from batch 2037862 because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency (EMA). Please note, other companies may distribute this medicine under the name gabapentin or the brand name Neurontin, but this recall only applies to this single batch of Gabapentin 100mg capsules in packs of 100 from Ranbaxy (UK) Limited.
The missing text should be positioned under the heading 'Take special care with' and states the following: 'A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming and killing themselves. If at any time you have these thoughts, immediately contact your doctor'
The patient information leaflet in other batches of the product has been updated.
For more information, please visit: more information here