Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# ...
FDA Recall #D-0841-2022 — Class II — March 31, 2022
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), 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
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,214,016 bottles
Distribution
Product was distributed nationwide
Code Information
Lot # H001149 4/30/2022 68180-215-06 H001602 5/31/2022 68180-215-06 H001884 6/30/2022 68180-215-06 H002539 8/31/2022 68180-215-06 H100944 4/30/2023 68180-215-06 H101054 4/30/2023 68180-215-06 H001150 4/30/2022 68180-215-09 H001151 4/30/2022 68180-215-09 H001152 4/30/2022 68180-215-09 H001532 5/31/2022 68180-215-09 H001533 5/31/2022 68180-215-09 H001534 5/31/2022 68180-215-09 H001535 5/31/2022 68180-215-09 H001536 5/31/2022 68180-215-09 H001603 5/31/2022 68180-215-09 H001604 5/31/2022 68180-215-09 H001605 5/31/2022 68180-215-09 H001606 5/31/2022 68180-215-09 H001607 5/31/2022 68180-215-09 H001608 5/31/2022 68180-215-09 H001885 6/30/2022 68180-215-09 H001886 6/30/2022 68180-215-09 H001887 6/30/2022 68180-215-09 H001888 6/30/2022 68180-215-09 H002171 7/31/2022 68180-215-09 H002172 7/31/2022 68180-215-09 H002173 7/31/2022 68180-215-09 H002174 7/31/2022 68180-215-09 H002175 7/31/2022 68180-215-09 H002540 8/31/2022 68180-215-09 H002541 8/31/2022 68180-215-09 H002542 8/31/2022 68180-215-09 H002543 8/31/2022 68180-215-09 H002544 8/31/2022 68180-215-09 H002545 8/31/2022 68180-215-09 H002976 10/31/2022 68180-215-09 H002977 10/31/2022 68180-215-09 H002978 10/31/2022 68180-215-09 H003131 11/30/2022 68180-215-09 H003132 11/30/2022 68180-215-09 H003133 11/30/2022 68180-215-09 H003134 11/30/2022 68180-215-09 H003135 11/30/2022 68180-215-09 H003136 11/30/2022 68180-215-09 H100302 1/31/2023 68180-215-09 H100303 1/31/2023 68180-215-09 H100304 1/31/2023 68180-215-09 H100340 1/31/2023 68180-215-09 H100341 1/31/2023 68180-215-09 H100657 2/28/2023 68180-215-09 H100658 2/28/2023 68180-215-09 H100659 2/28/2023 68180-215-09 H100660 2/28/2023 68180-215-09 H100661 2/28/2023 68180-215-09 H100662 2/28/2023 68180-215-09 H100945 4/30/2023 68180-215-09 H100946 4/30/2023 68180-215-09 H101051 4/30/2023 68180-215-09 H101052 4/30/2023 68180-215-09 H101053 4/30/2023 68180-215-09 H101055 4/30/2023 68180-215-09 H101056 4/30/2023 68180-215-09 H101057 4/30/2023 68180-215-09 H101058 4/30/2023 68180-215-09 H101286 5/31/2023 68180-215-09 H101287 5/31/2023 68180-215-09 H101288 5/31/2023 68180-215-09 H101289 5/31/2023 68180-215-09 H101581 6/30/2023 68180-215-09 H101582 6/30/2023 68180-215-09 H101583 6/30/2023 68180-215-09 H101584 7/31/2023 68180-215-09 H101585 7/31/2023 68180-215-09 H101790 7/31/2023 68180-215-09 H101791 7/31/2023 68180-215-09 H102078 8/31/2023 68180-215-09 H102079 8/31/2023 68180-215-09 H102080 9/30/2023 68180-215-09 H102118 9/30/2023 68180-215-09 H102119 9/30/2023 68180-215-09 H102120 9/30/2023 68180-215-09 H102125 9/30/2023 68180-215-09 H102126 9/30/2023 68180-215-09
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated