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- Recall Enforcement Event ID: 64835
Recall Enforment Report D-257-2013
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 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. 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 completed.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| 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 | Completed |
| 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. | Completed |
| 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. | Completed |
| 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. | Completed |
| 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.. | Completed |
| 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.. | Completed |
| 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. | Completed |
| 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. | Completed |
| 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.. | Completed |
| 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. | Completed |
| 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. | Completed |
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 |
Recall Enforcement Report D-257-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-261-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-259-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-253-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-251-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-255-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-260-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-252-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-254-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-258-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
Recall Enforcement Report D-256-2013
- 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
- Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
