Recall Enforment Report D-0283-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 01-05-2024 for the product Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06 The product was recalled due to subpotent drug and failed impurities/degradation specifications. The product was distributed in Product Was Distributed To 32 Wholesale/distributor Accounts Who Further Distributed The Product To 156 Distribution Sites. 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-0283-2024	01-05-2024	02-07-2024	Class II	15,576 Bottles	Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06	Subpotent Drug and Failed Impurities/Degradation Specifications	Ongoing
D-0284-2024	01-05-2024	02-07-2024	Class II	165,60 bottles	Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06	Subpotent Drug and Failed Impurities/Degradation Specifications	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68180-658	Rifampin	Rifampin	Capsule	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-659	Rifampin	Rifampin	Capsule	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	93753 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0283-2024 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 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites. 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	Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Reason For Recall	Subpotent Drug and Failed Impurities/Degradation Specifications What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	15,576 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	02-07-2024
Recall Initiation Date	01-05-2024 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	A200816 exp 1/2024 A201248 exp 3/2024 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	68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07
Status	Ongoing

Field Name	Field Value
Event ID	93753 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0284-2024 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 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites. 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	Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Reason For Recall	Subpotent Drug and Failed Impurities/Degradation Specifications What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	165,60 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	02-07-2024
Recall Initiation Date	01-05-2024 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	A200817 exp 1/2024 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	68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07
Status	Ongoing