Aurolife Pharma, Indian-based Aurobindo’s US subsidiary, issued the recall after it was discovered that a number of products had been labelled with the wrong lot number, as well as potentially bearing the incorrect expiry date.
The recall totals 2,352 bottles of simvastatin tablets, each of which contains 1,000 tablets.
Simvastatin tablets are used to lower cholesterol in individuals who have been diagnosed with high cholesterol.
The issue was revealed after an enforcement report notice from the US Food and Drug Administration (FDA). The report stated that the product was sold nationwide by three major distributors “who may have further distributed the product”.
A recall of the product was instigated on July 29, 2019.
In June 2019, it was revealed that parent company, Aurobindo, had received its third Form 483 of the year.
All three of the notifications were as a result of quality control issues at its Indian plants, with products produced at the relevant facilities destined for the US market.