D-0840-2022 Class II Terminated

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H100935, exp. date Mar-23 H001470,, exp. date Nov-22 H002842, exp. date Jan-23 H101081, exp. date Mar-23 H001484, exp. date Dec-22 H002843, exp. date Jan-23 H101148, exp. date Mar-23 H001485, exp. date Dec-22 H002995, exp. date Jan-23 H101639, exp. date Mar-23 H001708, exp. date Dec-22 H003199, exp. date Feb-23 H101480, exp. date Mar-23 H002314, exp. date Dec-22 H003200, exp. date Feb-23 H101822, exp. date Mar-23 H001709, exp. date Dec-22 H100028, exp. date Feb-23 H101481, exp. date Mar-23 H002001, exp. date Dec-22 H100712, exp. date Feb-23 H102288, exp. date Mar-23 H001991, exp. date Dec-22 H100221, exp. date Feb-23 H002000, exp. date Dec-22 H100222, exp. dateFeb-23 H903582, exp. date Oct-22 H001707, exp. dateDec-22 H100220, exp. date Feb-23 H000556,, exp. date Nov-22 H003045, exp. date Dec-22 H100901, exp. date Mar-23 H000557, exp. date Nov-22 H002391, exp. date Dec-22 H101078, exp. date Mar-23 H001061, exp. date Nov-22 H002312, exp. date Jan-23 H101479, exp. date Mar-23 H001062, exp. date Nov-22 H002517, exp. date Jan-23 H101496, exp. date Mar-23 H001431, exp. date Nov-22 H002841, exp. date Jan-23 H101821, exp. date Mar-23 H002341, exp. date Nov-22 H003044, exp. date Feb-23 H102286, exp. date Mar-23 H001706, exp. date Dec-22 H003198, exp. date Feb-23 H102287, exp. date Mar-23