Warning letters, 483s, Recalls, Import Alerts, Audit observations
Sandimmune (cyclosporine oral solution) 100 mg/mL,packaged in 50 mL bottles, is indicated for the prophylaxis
Glenmark has initiated a Class II recall of 37200 bottles of Indomethacin 25mg capsules and
Glenmark Pharmaceuticals Inc., USA is recalling one lot of Esomeprazole Magnesium Delayed-Release Capsules. The recall
Bayer is recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass
Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
Hospira recalled in US one lot of 4.2% Sodium bicarbonate injection and one lot each
Florida based VistaPharm LLC is recalling in US one lot of ulcer treatment drug Sucralfate
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of
