According to the information available on the UK-based Medicines and Healthcare products Regulatory Agency, it has asked Ranbaxy to recall three batches of Pravastatin 10 mg and 40 mg tablets.
The regulator said patient information leaflets (PILs) have not been updated to include approved safety warnings, some of which were mandatory and initiated by the European Medicines Agency (EMA). It has also asked pharmacists to quarantine the remaining stock of the above batches and return it to the wholesaler from which it was purchased, it added. Ranbaxy officials could not be reached for comments.
The drug regulator has also issued alert on few batches of Ranbaxy’s Simvastatin 20 mg and 40 mg tablets, which have not been updated to include approved safety warnings.
“Due to the potential for product shortages, affected batches are not being recalled. The PIL has already been corrected, and no further packs containing the incorrect PIL will enter the market,” it said.