Multi-event July 2012 FDA Recall Drug by Lloyd Inc. Of Iowa

This Multi-event Class II drug recall was voluntarily initiated by Lloyd Inc. Of Iowa on July 9, 2012 for the product Drug. The FDA reported the reason for recall as cgmp deviations; does not meet in process specification requirements. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-079-2013 TERMINATED D-083-2013 TERMINATED D-082-2013 TERMINATED D-074-2013 TERMINATED D-076-2013 TERMINATED D-081-2013 TERMINATED D-085-2013 TERMINATED D-075-2013 TERMINATED D-080-2013 TERMINATED D-084-2013 TERMINATED D-078-2013 TERMINATED D-077-2013 TERMINATED

Recall Number: D-079-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
37,827/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1096371, exp. 5/312013; and #1092299, exp. 1/31/2013

Recall Number: D-083-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
36,978/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1095212 exp. 4/30/2013; and #1088877, exp. 11/30/2012

Recall Number: D-082-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
3,774,541 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HA27911 and #HA12511

Recall Number: D-074-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
1,923,887 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HB01212

Recall Number: D-076-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
3,826,269 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HA31411 and #HE17811

Recall Number: D-081-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
19,162/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1095210, exp. 4/30/2013

Recall Number: D-085-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
1,443/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1097178 exp. 7/31/2013

Recall Number: D-075-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
13,692/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1097830 exp. 1/31/2013

Recall Number: D-080-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
1,924,174 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HB27811

Recall Number: D-084-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
1,902,957 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HE35311

Recall Number: D-078-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
3,813,645 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# HC31411 and #HE18711

Recall Number: D-077-2013

Reason for Recall
cGMP Deviations; does not meet in process specification requirements
Initiated
07-09-2012
Reported
12-12-2012
Quantity
31,252/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lloyd Inc. of Iowa
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# 1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012