Recall Enforment Report D-253-2013

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 03-28-2013 for the product Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. The product was recalled due to chemical contamination: emission of strong odor after package was opened.. 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-253-2013	03-28-2013	04-24-2013	Class II	37809 bottles	Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-259-2013	03-28-2013	04-24-2013	Class II	36045 bottles	Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-251-2013	03-28-2013	04-24-2013	Class II	23210 bottles	Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened..	Ongoing
D-255-2013	03-28-2013	04-24-2013	Class II	18195 bottles	Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened..	Ongoing
D-256-2013	03-28-2013	04-24-2013	Class II	9213 bottles	Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-257-2013	03-28-2013	04-24-2013	Class II	37891 bottles	Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened	Ongoing
D-261-2013	03-28-2013	04-24-2013	Class II	14464 bottles	Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-252-2013	03-28-2013	04-24-2013	Class II	29613 bottles	Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-260-2013	03-28-2013	04-24-2013	Class II	10121 bottles	Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing
D-254-2013	03-28-2013	04-24-2013	Class II	26447 bottles	Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened..	Ongoing
D-258-2013	03-28-2013	04-24-2013	Class II	7901 bottles	Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.	Chemical contamination: emission of strong odor after package was opened.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
60793-850	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-851	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-852	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-853	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-854	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-855	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-856	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-857	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-858	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-859	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug
60793-860	Levoxyl	Levothyroxine Sodium	Tablet	Oral	Pfizer Laboratories Div Pfizer Inc	Human Prescription Drug

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-253-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	37809 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-259-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	36045 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-251-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened.. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	23210 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-255-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened.. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	18195 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-256-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9213 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-257-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	37891 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-261-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14464 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-252-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	29613 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-260-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10121 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-254-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened.. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	26447 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing

Field Name	Field Value
Event ID	64835 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-258-2013 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 and PR 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	Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Reason For Recall	Chemical contamination: emission of strong odor after package was opened. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7901 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	04-24-2013
Recall Initiation Date	03-28-2013 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	Pfizer Inc.
Code Info	Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14 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	60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01
Status	Ongoing