Mumbai: Recently a pharmaceutical company had recalled 12,480 bottles of Paroxetine tablets on account of failed dissolution specifications from the US market. A 3-month-old term stability study was done for the same and as per the United States Food and Drug Administration (USFDA), this was a Class III recall. Another company from the USA has just recalled 3.31 lakh bottles of Divalproex Sodium which is used for the treatment of seizures and manic episodes in people with bipolar disorder.
There have been several other instances wherein drugs are being recalled either on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. Besides the issues of faulty labeling, several companies are suffering recalls because they have failed to meet the World Health Organization-Good Manufacturing Practices (WHO- GMP) standards. Primarily, companies are skipping essential steps of purchasing an approved Reference Listed Drug. A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
The various types of pharma product recall include:
Class I recall: It is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: It is a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: It is a situation in which use of or exposure to a volatile product is not likely to cause adverse health consequences.
Medical device safety alert: It is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.