Multi-event February 2012 FDA Recall Drug by Lloyd Inc

This Multi-event Class II drug recall was voluntarily initiated by Lloyd Inc on February 3, 2012 for the product Drug. The FDA reported the reason for recall as subpotent (single ingredient drug). The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1392-2012 TERMINATED D-1393-2012 TERMINATED

Recall Number: D-1392-2012

Reason for Recall
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Initiated
02-03-2012
Reported
07-04-2012
Quantity
1,924,297 bulk tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61094
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
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.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2013
Product Description About Product Description
Full technical description of the product.
Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Batch or Lot Expiration Information

Lot# Lot HB06311

Recall Number: D-1393-2012

Reason for Recall
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Initiated
02-03-2012
Reported
07-04-2012
Quantity
19,166 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61094
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
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.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2013
Product Description About Product Description
Full technical description of the product.
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, 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 1087589