Warning letters, 483s, Recalls, Import Alerts, Audit observations
Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for
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
Strides recalled 2700 bottles of Losartan Potassium USP 25 mg tablets in US for presence
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA
In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India
