U.S. RESIDENTS NOTIFIED OF UK COUNTERFEIT LIPITOR RECALL
British health regulators have recalled a counterfeit batch of Pfizer's cholesterol drug Lipitor in the UK, according to an FDA consumer alert.
Tests performed on the affected product by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) indicate no immediate risk to patients, the FDA said in the alert. But the MHRA also has advised those taking the drug to discontinue its use and recommended that UK pharmacies return what remains of the counterfeit batch to Pfizer, according to the FDA.
Meanwhile, U.S. residents who bought FDA-approved Lipitor (atorvastatin calcium) through legal U.S. pharmacies should not have received the counterfeit product and are not affected by the recall, the FDA said. However, consumers who purchased the drug from the UK through state-run importation programs or through sources that do not supply FDA-approved pharmaceutical products may have received the affected drugs, the FDA said.
The affected batch is sold in 20 mg doses in packages of 28 tablets marked with batch number "004405K1" and an "11 2007" expiration date.