Class II Recall

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-co

Summary

The FDA issued a Class II for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-cou by Lupin Pharmaceuticals Inc.. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Details

Source

Drug Recall

External ID

D-0841-2022

Action Date

2022-05-11

Status

Terminated

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.

Lot/Code Info: 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

Quantity Affected: 1,214,016 bottles

Reason for Recall

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

Distribution

Product was distributed nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2022-03-31

Company

Lupin Pharmaceuticals Inc.

Baltimore, MD

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Lupin Pharmaceuticals Inc. have FDA actions?

Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0841-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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