Recall Enforment Report D-0841-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 03-31-2022 for the product 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. The product was recalled due to cgmp deviations- azido impurity levels observed to be above acceptable limits. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0841-2022	03-31-2022	05-11-2022	Class II	1,214,016 bottles	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.	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated
D-0840-2022	03-31-2022	05-11-2022	Class II	1,247,067 bottles	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	Terminated
D-0838-2022	03-31-2022	05-11-2022	Class II	657,336 bottles	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.	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated
D-0839-2022	03-31-2022	05-11-2022	Class II	1,466,150 bottles	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.	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated
D-0843-2022	03-31-2022	05-11-2022	Class II	2,361,924 bottles	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), 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	Terminated
D-0842-2022	03-31-2022	05-11-2022	Class II	303,696 bottles	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), 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	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68180-210	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-211	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-212	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-215	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-216	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-217	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-307	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-308	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-309	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-376	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-377	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-378	Losartan Potassium	Losartan Potassium	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0841-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,214,016 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0840-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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.
Reason For Recall	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,247,067 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0838-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	657,336 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0839-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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.
Reason For Recall	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,466,150 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0843-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), 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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2,361,924 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
Code Info	Lot # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-09 H001795 6/30/2022 68180-216-09 H001796 6/30/2022 68180-216-09 H001797 6/30/2022 68180-216-09 H001879 6/30/2022 68180-216-09 H001880 6/30/2022 68180-216-09 H001881 6/30/2022 68180-216-09 H001942 6/30/2022 68180-216-09 H001943 6/30/2022 68180-216-09 H001944 6/30/2022 68180-216-09 H001945 6/30/2022 68180-216-09 H001946 6/30/2022 68180-216-09 H002179 7/31/2022 68180-216-09 H002180 7/31/2022 68180-216-09 H002181 8/31/2022 68180-216-09 H002182 8/31/2022 68180-216-09 H002183 8/31/2022 68180-216-09 H002237 8/31/2022 68180-216-09 H002238 8/31/2022 68180-216-09 H002239 8/31/2022 68180-216-09 H002240 8/31/2022 68180-216-09 H002241 8/31/2022 68180-216-09 H002627 9/30/2022 68180-216-09 H002628 9/30/2022 68180-216-09 H002629 9/30/2022 68180-216-09 H002630 9/30/2022 68180-216-09 H002631 9/30/2022 68180-216-09 H002979 11/30/2022 68180-216-09 H002980 11/30/2022 68180-216-09 H002981 11/30/2022 68180-216-09 H002982 11/30/2022 68180-216-09 H002983 11/30/2022 68180-216-09 H100112 12/31/2022 68180-216-09 H100113 12/31/2022 68180-216-09 H100114 12/31/2022 68180-216-09 H100115 12/31/2022 68180-216-09 H100116 12/31/2022 68180-216-09 H100156 12/31/2022 68180-216-09 H100157 12/31/2022 68180-216-09 H100622 2/28/2023 68180-216-09 H100623 2/28/2023 68180-216-09 H100624 2/28/2023 68180-216-09 H100625 2/28/2023 68180-216-09 H100626 2/28/2023 68180-216-09 H100627 2/28/2023 68180-216-09 H100628 2/28/2023 68180-216-09 H100629 2/28/2023 68180-216-09 H100939 4/30/2023 68180-216-09 H100940 4/30/2023 68180-216-09 H100941 4/30/2023 68180-216-09 H100942 4/30/2023 68180-216-09 H100943 4/30/2023 68180-216-09 H101094 5/31/2023 68180-216-09 H101095 5/31/2023 68180-216-09 H101096 5/31/2023 68180-216-09 H101097 5/31/2023 68180-216-09 H101098 5/31/2023 68180-216-09 H101151 5/31/2023 68180-216-09 H101152 5/31/2023 68180-216-09 H101290 5/31/2023 68180-216-09 H101291 5/31/2023 68180-216-09 H101292 5/31/2023 68180-216-09 H101293 5/31/2023 68180-216-09 H101323 5/31/2023 68180-216-09 H101324 5/31/2023 68180-216-09 H101823 7/31/2023 68180-216-09 H101824 7/31/2023 68180-216-09 H101825 7/31/2023 68180-216-09 H101853 8/31/2023 68180-216-09 H101854 8/31/2023 68180-216-09 H101855 8/31/2023 68180-216-09 H101856 8/31/2023 68180-216-09 H102127 9/30/2023 68180-216-09 H102128 9/30/2023 68180-216-09 H102129 9/30/2023 68180-216-09 H102130 9/30/2023 68180-216-09 H102150 9/30/2023 68180-216-09 H102151 9/30/2023 68180-216-09 H102152 9/30/2023 68180-216-09 H102153 9/30/2023 68180-216-09 H102154 9/30/2023 68180-216-09 H102155 9/30/2023 68180-216-09 H102201 9/30/2023 68180-216-09 H102223 9/30/2023 68180-216-09 H102268 9/30/2023 68180-216-09 H102269 9/30/2023 68180-216-09 H102270 9/30/2023 68180-216-09 H102271 9/30/2023 68180-216-09 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	89916 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0842-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), 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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	303,696 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-11-2022
Recall Initiation Date	03-31-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-22-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Lupin Pharmaceuticals Inc.
Code Info	Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001358 5/31/2022 68180-217-09 H001359 5/31/2022 68180-217-09 H001371 5/31/2022 68180-217-09 H001372 5/31/2022 68180-217-09 H001373 5/31/2022 68180-217-09 H001374 5/31/2022 68180-217-09 H001375 5/31/2022 68180-217-09 H001628 5/31/2022 68180-217-09 H001629 5/31/2022 68180-217-09 H001630 6/30/2022 68180-217-09 H001645 6/30/2022 68180-217-09 H001646 6/30/2022 68180-217-09 H001647 6/30/2022 68180-217-09 H001798 6/30/2022 68180-217-09 H001799 6/30/2022 68180-217-09 H001882 6/30/2022 68180-217-09 H001883 6/30/2022 68180-217-09 H001948 6/30/2022 68180-217-09 H001949 6/30/2022 68180-217-09 H001985 6/30/2022 68180-217-09 H001986 6/30/2022 68180-217-09 H001987 7/31/2022 68180-217-09 H001988 7/31/2022 68180-217-09 H001989 7/31/2022 68180-217-09 H001990 7/31/2022 68180-217-09 H002243 8/31/2022 68180-217-09 H002244 8/31/2022 68180-217-09 H002245 8/31/2022 68180-217-09 H002315 8/31/2022 68180-217-09 H002316 8/31/2022 68180-217-09 H002317 8/31/2022 68180-217-09 H002318 8/31/2022 68180-217-09 H002319 8/31/2022 68180-217-09 H002320 8/31/2022 68180-217-09 H002321 8/31/2022 68180-217-09 H002322 8/31/2022 68180-217-09 H002323 8/31/2022 68180-217-09 H002324 8/31/2022 68180-217-09 H002632 9/30/2022 68180-217-09 H002633 9/30/2022 68180-217-09 H002634 9/30/2022 68180-217-09 H002635 9/30/2022 68180-217-09 H002636 9/30/2022 68180-217-09 H002765 9/30/2022 68180-217-09 H002766 9/30/2022 68180-217-09 H002767 9/30/2022 68180-217-09 H002768 9/30/2022 68180-217-09 H002769 9/30/2022 68180-217-09 H002770 9/30/2022 68180-217-09 H003194 11/30/2022 68180-217-09 H003195 11/30/2022 68180-217-09 H100009 12/31/2022 68180-217-09 H100010 12/31/2022 68180-217-09 H100021 12/31/2022 68180-217-09 H100022 12/31/2022 68180-217-09 H100023 12/31/2022 68180-217-09 H100029 12/31/2022 68180-217-09 H100030 12/31/2022 68180-217-09 H100342 1/31/2023 68180-217-09 H100343 1/31/2023 68180-217-09 H100344 1/31/2023 68180-217-09 H100345 1/31/2023 68180-217-09 H100346 1/31/2023 68180-217-09 H100374 1/31/2023 68180-217-09 H100375 1/31/2023 68180-217-09 H100376 1/31/2023 68180-217-09 H100377 1/31/2023 68180-217-09 H100378 1/31/2023 68180-217-09 H100452 1/31/2023 68180-217-09 H100453 1/31/2023 68180-217-09 H100454 2/28/2023 68180-217-09 H100458 2/28/2023 68180-217-09 H100459 2/28/2023 68180-217-09 H100652 2/28/2023 68180-217-09 H100653 2/28/2023 68180-217-09 H100654 2/28/2023 68180-217-09 H100655 2/28/2023 68180-217-09 H100656 2/28/2023 68180-217-09 H100687 2/28/2023 68180-217-09 H100688 2/28/2023 68180-217-09 H100689 2/28/2023 68180-217-09 H100703 2/28/2023 68180-217-09 H100704 2/28/2023 68180-217-09 H100891 3/31/2023 68180-217-09 H100892 3/31/2023 68180-217-09 H100902 3/31/2023 68180-217-09 H100903 3/31/2023 68180-217-09 H100904 3/31/2023 68180-217-09 H100905 3/31/2023 68180-217-09 H100936 3/31/2023 68180-217-09 H100937 3/31/2023 68180-217-09 H100938 3/31/2023 68180-217-09 H101153 5/31/2023 68180-217-09 H101154 5/31/2023 68180-217-09 H101155 5/31/2023 68180-217-09 H101156 5/31/2023 68180-217-09 H101157 5/31/2023 68180-217-09 H101158 5/31/2023 68180-217-09 H101159 5/31/2023 68180-217-09 H101294 5/31/2023 68180-217-09 H101295 5/31/2023 68180-217-09 H101296 5/31/2023 68180-217-09 H101297 5/31/2023 68180-217-09 H101325 5/31/2023 68180-217-09 H101326 6/30/2023 68180-217-09 H101327 6/30/2023 68180-217-09 H101328 6/30/2023 68180-217-09 H101349 6/30/2023 68180-217-09 H101350 6/30/2023 68180-217-09 H101351 6/30/2023 68180-217-09 H101352 6/30/2023 68180-217-09 H101482 6/30/2023 68180-217-09 H101483 6/30/2023 68180-217-09 H101606 7/31/2023 68180-217-09 H101618 7/31/2023 68180-217-09 H101619 7/31/2023 68180-217-09 H101620 7/31/2023 68180-217-09 H101621 7/31/2023 68180-217-09 H101827 7/31/2023 68180-217-09 H101828 7/31/2023 68180-217-09 H101829 7/31/2023 68180-217-09 H101857 7/31/2023 68180-217-09 H101858 7/31/2023 68180-217-09 H101911 7/31/2023 68180-217-09 H101912 7/31/2023 68180-217-09 H101913 7/31/2023 68180-217-09 H102455 10/31/2023 68180-217-09 H102456 10/31/2023 68180-217-09 H102457 10/31/2023 68180-217-09 H102458 10/31/2023 68180-217-09 H102485 10/31/2023 68180-217-09 H102489 10/31/2023 68180-217-09 H102490 10/31/2023 68180-217-09 H102491 10/31/2023 68180-217-09 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.