Ranbaxy recalls nerve pain drug from UK market
04 Jun 2010
Ranbaxy Laboratories' UK subsidiary is recalling all unused stock of Gabapentin 100mg capsules, used in the treatment of nerve pain, from the UK market to update patient information leaflet.
Ranbaxy (UK) Limited today initiated the recall of a batch (batch no 2037862) of its anti-epilepsy drug Gabapentin as the patient information leaflet failed to include safety warning as required by the European regulating body, the European Medicines Agency.
This is the second recall made by one of the world's top 10 generic manufacturing companies after having been forced to select batches of two of its anti-depressants from select European markets late last month.
The UK health regulator, Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement, ''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 regulator said that the patient information leaflet has been updated in subsequent batches of the product.
The MHRA asked pharmacists to quarantine all remaining stock of the drug and return it to the wholesaler from which it was purchased.