Drug product
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
D-0839-2022
Product summary
- Event
- Event 89916
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,466,150 bottles
- Official record key
drug-enforcement:D-0839-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Code information: H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, exp. date Dec-22 H003003, exp. date Feb-23 H000849, exp. date Nov-22 H002127, exp. date Dec-22 H003004, exp. date Feb-23 H001412, exp. date Nov-22 H002128, exp. date Dec-22 H003123, exp. date Feb-23 H001413, exp. date Nov-22 H002643, exp. date Jan-23 H003124, exp. date Feb-23 H001414, exp. date Nov-22 H002644, exp. date Jan-23 H101129, exp. date Feb-23 H001430, exp. date Nov-22 H002645, exp. date Jan-23 H101147, exp. date Mar-23 H001526, exp. date Dec-22 H002839, exp. date Jan-23 H102139, exp. date Mar-23 H001652, exp. date Dec-22 H002840, exp. date Jan-23 H102158, exp. date Mar-23 H000605, exp. date Jan-23 H001599, exp. date Dec-22 H100148, exp. date Feb-23 H001401, exp. date Nov-22 H001875, exp. date Dec-22 H102043, exp. date Mar-23 H001063, exp. date Nov-22 H002126, exp. date Dec-22 H101495, exp. date Mar-23 H001188, exp. date Nov-22 H002838, exp. date Jan-23 H001455, exp. date Nov-22 H002642, exp. date Jan-23
Distribution pattern: Product was distributed nationwide
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations