Recall Enforment Report D-1493-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Lupin Limited, originally initiated on 02-19-2016 for the product Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03 The product was recalled due to cgmp deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.. The product was distributed in Us No Recalled Product Was Distributed To Any Foreign Consignees By Lupin. 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-1493-2016	02-19-2016	09-14-2016	Class III	11,812 bottles	Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.	Terminated
D-1492-2016	02-19-2016	09-14-2016	Class III	43,536 bottles	Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68180-719	Amlodipine Besylate	Amlodipine Besylate	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-720	Amlodipine Besylate	Amlodipine Besylate	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-721	Amlodipine Besylate	Amlodipine Besylate	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug
68180-751	Amlodipine Besylate	Amlodipine Besylate	Tablet	Oral	Lupin Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	74964 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1493-2016 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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	US No recalled product was distributed to any foreign consignees by Lupin. 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	Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Reason For Recall	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	11,812 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	09-14-2016
Recall Initiation Date	02-19-2016 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-03-2017 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail 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 Limited
Code Info	Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016 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	68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-09; 68180-719-03; 68180-720-09; 68180-720-03; 68180-721-09; 68180-721-03
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	74964 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1492-2016 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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	US No recalled product was distributed to any foreign consignees by Lupin. 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	Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Reason For Recall	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	43,536 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	09-14-2016
Recall Initiation Date	02-19-2016 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-03-2017 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail 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 Limited
Code Info	Lot #: G304799, Exp. 4/2016 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	68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-09; 68180-719-03; 68180-720-09; 68180-720-03; 68180-721-09; 68180-721-03
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.