The affected lot has been manufactured at the company's Pithampur plant in Madhya Pradesh and marketed in the US market by Baltimore-based Lupin Pharmaceuticals Inc. The USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing". The company initiated the Class III nationwide (US) recall of the affected lot on January 23 this year.
