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- FDA Recall: Irbesartan
FDA Recall Irbesartan
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Irbesartan with NDC 68180-411 was initiated on 10-12-2021 as a Class II recall due to cgmp deviations: impurity n-nitrosoirbesartan detected in api The latest recall number for this product is D-0086-2022 and the recall is currently terminated as of 01-30-2023 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0086-2022 | 10-12-2021 | 11-10-2021 | Class II | 51,144 bottles | Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only | Terminated |
| D-0088-2022 | 10-12-2021 | 11-10-2021 | Class II | 119,544 bottles | Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only | Terminated |
| D-0087-2022 | 10-12-2021 | 11-10-2021 | Class II | 134,016 bottles | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only | 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-0086-2022
- Event ID
- 88856 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0086-2022 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 to major distributors who may have further distributed the product 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
- Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
- Reason For Recall
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 51,144 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
- 11-10-2021
- Recall Initiation Date
- 10-12-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-30-2023 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
- a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022 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
- 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
- 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-0088-2022
- Event ID
- 88856 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0088-2022 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 to major distributors who may have further distributed the product 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
- Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
- Reason For Recall
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 119,544 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
- 11-10-2021
- Recall Initiation Date
- 10-12-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-30-2023 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
- a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022 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
- 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
- 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-0087-2022
- Event ID
- 88856 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0087-2022 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 to major distributors who may have further distributed the product 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
- Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
- Reason For Recall
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 134,016 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
- 11-10-2021
- Recall Initiation Date
- 10-12-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-30-2023 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
- a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022 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
- 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
- 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.