Recall Enforment Report D-1092-2014

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 01-24-2014 for the product Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. The product was recalled due to cgmp deviations: ethambutol hydrochloride tablets, usp, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.. 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-1092-2014	01-24-2014	03-12-2014	Class II	10405 tablets	Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.	CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.	Terminated
D-1093-2014	01-24-2014	03-12-2014	Class II	2494 capsules	Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.	Terminated
D-1095-2014	01-24-2014	03-12-2014	Class II	35746 capsules	Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.	Terminated
D-1094-2014	01-24-2014	03-12-2014	Class II	9796 tablets	Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.	CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Capsule	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0323	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Capsule	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Capsule	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0775	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0776	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0777	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0971	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0972	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0973	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-0974	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	67412 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1092-2014 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	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	Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Reason For Recall	CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10405 tablets 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	03-12-2014
Recall Initiation Date	01-24-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-08-2014 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	Teva Pharmaceuticals USA
Code Info	Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16. 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.
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	67412 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1093-2014 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	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	Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
Reason For Recall	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2494 capsules 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	03-12-2014
Recall Initiation Date	01-24-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-08-2014 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	Teva Pharmaceuticals USA
Code Info	Lot # 34017426A, Exp. 10/16. 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	0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02
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	67412 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1095-2014 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	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	Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
Reason For Recall	CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	35746 capsules 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	03-12-2014
Recall Initiation Date	01-24-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-08-2014 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	Teva Pharmaceuticals USA
Code Info	Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16. 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	0555-0323-02; 0555-0323-04; 0555-0302-02; 0555-0302-04; 0555-0324-02
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	67412 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1094-2014 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	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	Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Reason For Recall	CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9796 tablets 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	03-12-2014
Recall Initiation Date	01-24-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-08-2014 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	Teva Pharmaceuticals USA
Code Info	Lot # 34017575A, Exp. 10/16. 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	0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02
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.