D-0838-2022 Class II Terminated
FDA drug recall D-0838-2022 was initiated by Lupin Pharmaceuticals Inc. on Mar 31, 2022 and is designated Class II. Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits The recall status is terminated (terminated May 22, 2023). Affected quantity: 657,336 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- Mar 31, 2022
- Termination Date
- May 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 657,336 bottles
Product Description
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution Pattern
Product was distributed nationwide
Code Information
H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, exp. date Jan-23 H101285, exp. date Feb-23 H001714, exp. date Dec-22 H000523, exp. date Jan-23 H101989, exp. date Mar-23 H001940, exp. date Dec-22 H003080, exp. date Jan-23 H101789, exp. date Mar-23 H002388, exp. date Jan-23 H100109, exp. date Feb-23 H002389, exp. date Jan-23 H100642, exp. date Feb-23 H000848, exp. date Nov-22, H002002, exp. date Dec-22 H100110, exp. date Feb-23 H001190, exp. date Nov-22 H002003, exp. date Dec-22 H100111, exp. date Feb-23 H001191, exp. date Nov-22 H002489, exp. date Jan-23 H100146, exp. date Feb-23 H001192, exp. date Nov-22 H002390, exp. date Jan-23 H100147, exp. date Feb-23 H001058, exp. date Nov-22 H002486, exp. date Jan-23 H101283, exp. date Feb-23 H000985, exp. date Nov-22 H002487, exp. date Jan-23 H101284, exp. date Feb-23 H001059, exp. date Nov-22 H002488, exp. date Jan-23 H100643, exp. date Feb-23 H001275, exp. date Nov-22 H002787, exp. date Jan-23 H100644, exp. date Mar-23 H001715, exp. date Dec-22 H002957, exp. date Jan-23 H100869, exp. date Mar-23 H001716, exp. date Dec-22 H002958, exp. date Jan-23 H101990, exp. date Mar-23 H001717, exp. date Dec-22 H003079, exp. date Jan-23 H101991, exp. date Mar-23 H001718, exp. date Dec-22 H003121, exp. date Feb-23 H101992, exp. date Mar-23 H001941, exp. date Dec-22 H003122, exp. date Feb-23 H000847, exp. date Nov 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0838-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026