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 25, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; 9-month stability interval. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-103-2013 TERMINATED D-102-2013 TERMINATED D-101-2013 TERMINATED D-100-2013 TERMINATED

Recall Number: D-103-2013

Reason for Recall
Subpotent; 9-month stability interval
Initiated
07-25-2012
Reported
01-02-2013
Quantity
16,548/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62664
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide and to 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), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# Lot 1094098, exp. date 9/2012

Recall Number: D-102-2013

Reason for Recall
Subpotent; 9-month stability interval
Initiated
07-25-2012
Reported
01-02-2013
Quantity
1,924,133/75-mcg. tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62664
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide and to 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 0.075 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# Lot HF23111

Recall Number: D-101-2013

Reason for Recall
Subpotent; 9-month stability interval
Initiated
07-25-2012
Reported
01-02-2013
Quantity
37,441/100-tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62664
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide and to 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# Lot 1093992 and 1094095, exp. date 9/2012

Recall Number: D-100-2013

Reason for Recall
Subpotent; 9-month stability interval
Initiated
07-25-2012
Reported
01-02-2013
Quantity
3,789,426/50-mcg. tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62664
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distribution was nationwide and to 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# Lot HB23111 and HC23111