Recall Enforment Report D-425-2013

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by King Legacy, a wholly owned subsidiary of Pfizer, originally initiated on 04-30-2013 for the product 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 The product was recalled due to subpotent drug: the products were below specification for potency at the expiry stability point.. 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-425-2013	04-30-2013	05-29-2013	Class II	195,201 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-427-2013	04-30-2013	05-29-2013	Class II	103,796 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-430-2013	04-30-2013	05-29-2013	Class II	51,438 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-422-2013	04-30-2013	05-29-2013	Class II	195,699 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-426-2013	04-30-2013	05-29-2013	Class II	107,236 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-428-2013	04-30-2013	05-29-2013	Class II	77,272 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-423-2013	04-30-2013	05-29-2013	Class II	194,142 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-421-2013	04-30-2013	05-29-2013	Class II	51,591 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-431-2013	04-30-2013	05-29-2013	Class II	33,227 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-424-2013	04-30-2013	05-29-2013	Class II	112,914 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated
D-429-2013	04-30-2013	05-29-2013	Class II	56,405 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	Subpotent Drug: The products were below specification for potency at the expiry stability point.	Terminated

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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-425-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	195,201 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-427-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	103,796 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-430-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	51,438 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-422-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	195,699 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-426-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	107,236 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-428-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	77,272 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-423-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	194,142 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-421-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	51,591 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-431-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	33,227 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-424-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	112,914 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13 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	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	65172 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-429-2013 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 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	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	Subpotent Drug: The products were below specification for potency at the expiry stability point. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	56,405 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	05-29-2013
Recall Initiation Date	04-30-2013 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	06-30-2016 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	King Legacy, a wholly owned subsidiary of Pfizer
Code Info	Lot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13 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	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.