Recall Enforment Report D-0011-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Boehringer Ingelheim Roxane Inc, originally initiated on 09-25-2015 for the product FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8. The product was recalled due to cgmp deviations: the active pharmaceutical ingredient (api) intended for use in furosemide oral solution usp was inadvertently used to manufacture the recalled furosemide tablets usp.. The product was distributed nationwide 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-0011-2016	09-25-2015	10-21-2015	Class III	11,110 bottles	FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.	Terminated
D-0012-2016	09-25-2015	10-21-2015	Class III	5,160 bottles	FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0054-3294	Furosemide	Furosemide	Solution	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-3298	Furosemide	Furosemide	Solution	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-4297	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-4299	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-4301	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-8297	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-8299	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug
0054-8301	Furosemide	Furosemide	Tablet	Oral	Hikma Pharmaceuticals Usa Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	72234 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0011-2016 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	Nationwide and Puerto Rico 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	FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reason For Recall	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	11,110 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	10-21-2015
Recall Initiation Date	09-25-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2016 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	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	Boehringer Ingelheim Roxane Inc
Code Info	Lot #: 559660P, 559661P, Exp 03/17 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	0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46
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	72234 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0012-2016 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	Nationwide and Puerto Rico 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	FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
Reason For Recall	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5,160 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	10-21-2015
Recall Initiation Date	09-25-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2016 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	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	Boehringer Ingelheim Roxane Inc
Code Info	Lot #: 559310P, Exp 02/17; 559664B, Exp 04/17 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	0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46
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.