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- 68180-210
- FDA Recall: Losartan Potassium
FDA Recall Losartan Potassium
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Losartan Potassium with NDC 68180-210 was initiated on 03-31-2022 as a Class II recall due to cgmp deviations- azido impurity levels observed to be above acceptable limits The latest recall number for this product is D-0840-2022 and the recall is currently terminated as of 05-22-2023 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| 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. | 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. | 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. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
Recall Enforcement Report D-0840-2022
- 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.
Recall Enforcement Report D-0838-2022
- 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.
Recall Enforcement Report D-0839-2022
- 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.