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Ranbaxy to recall batches of anti-cholesterol drug from UK

Press Trust of India  |  New Delhi 

UK's drug regulator has asked Indian pharmaceutical firm to recall three batches of its anti-cholesterol tablets, on failure to update safety warnings in its information leaflets.

As per information available on the UK-based Medicines and Healthcare products Regulatory Agency (MHRA), it has asked to recall three batches of 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 all remaining stock of the above batches and return it to the wholesaler from which it was purchased, it added.

officials could not be reached for comments.

The drug regulator has also issued alert on few batches of Ranbaxy's 20 mg and 40 mg tablets, which have not been updated to include approved safety warnings, some of which were mandatory and initiated by the European Medicines Agency.

"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.

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UK's drug regulator has asked Indian pharmaceutical firm to recall three batches of its anti-cholesterol tablets, on failure to update safety warnings in its information leaflets.

As per information available on the UK-based Medicines and Healthcare products Regulatory Agency (MHRA), it has asked to recall three batches of 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 all remaining stock of the above batches and return it to the wholesaler from which it was purchased, it added.

officials could not be reached for comments.

The drug regulator has also issued alert on few batches of Ranbaxy's 20 mg and 40 mg tablets, which have not been updated to include approved safety warnings, some of which were mandatory and initiated by the European Medicines Agency.

"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.

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Business Standard
177 22

Ranbaxy to recall batches of anti-cholesterol drug from UK

UK's drug regulator has asked Indian pharmaceutical firm to recall three batches of its anti-cholesterol tablets, on failure to update safety warnings in its information leaflets.

As per information available on the UK-based Medicines and Healthcare products Regulatory Agency (MHRA), it has asked to recall three batches of 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 all remaining stock of the above batches and return it to the wholesaler from which it was purchased, it added.

officials could not be reached for comments.

The drug regulator has also issued alert on few batches of Ranbaxy's 20 mg and 40 mg tablets, which have not been updated to include approved safety warnings, some of which were mandatory and initiated by the European Medicines Agency.

"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.

image
Business Standard
177 22