Recall Enforment Report D-0089-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 12-07-2022 for the product Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 The product was recalled due to cgmp deviations: detection of n-nitroso-quinapril impurity above the acceptable daily intake limit.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0089-2023	12-07-2022	12-28-2022	Class II	23,736	Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Ongoing
D-0088-2023	12-07-2022	12-28-2022	Class II	30,612 bottles	Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68180-554	Quinapril	Quinapril	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-557	Quinapril	Quinapril	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-558	Quinapril	Quinapril	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-559	Quinapril	Quinapril	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	91279 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0089-2023 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 by major distribution chains 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	Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Reason For Recall	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	23,736 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	12-28-2022
Recall Initiation Date	12-07-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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 #: G102929, Exp 04/2023 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	68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09
Status	Ongoing

Field Name	Field Value
Event ID	91279 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0088-2023 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 by major distribution chains 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	Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
Reason For Recall	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	30,612 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	12-28-2022
Recall Initiation Date	12-07-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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 #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024 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	68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09
Status	Ongoing