The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has ordered the recall of 100 batches of drugs sold by generics firm Karib Kem Pharm.
The MHRA said that the move “follows evidence that the medicines, contract manufactured in India, were exposed to unsatisfactory conditions during shipment by sea, potentially causing them to deteriorate over time.”
The agency added that although the drugs in question had been cleared following examination when the arrived in Europe “testing is a sampling activity which examines a sample of the batch and only reflects the condition at the time of testing.”
It also said that it has not received any reports of adverse events associated with any of the products covered by the recall order.
A list of the affected products is available here . Further analysis is currently underway. Karib has not yet published a statement.