IGMPI India



USFDA orders for recalls of drug products from three pharmaceutical firms

US Food and Drug Administration (FDA) has ordered the recall of all drug products from Allied Pharmaceutical Laboratories Inc., Doctors Pharmaceuticals Inc. and Morishita-Seggs Pharmaceuticals Inc. Recalled product were manufactured from January 2014 up to present by Allied Pharmaceutical and Morishita-Seggs Pharmaceuticals and those produced since March last year by Doctors Pharmaceuticals. UFDA ordered for recall due to “critical and major findings” of noncompliance with international good manufacturing practice standard for medicines.

About the recall FDA stated that “Critical and major findings of nonconformance to Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme -Good Manufacturing Practice (PIC/S-GMP) were noted upon inspection of the said manufacturing (facilities), which indicates that there is no assurance that the manufactured products are of good quality”.

FDA also ordered all the three firms to stop their manufacturing operations in three separate advisories.