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 24, 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
Recall Number: D-1395-2012
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
02-24-2012
07-04-2012
1,913,236 tablets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
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.
General area of initial distribution.
Nationwide
07-30-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601.
Batch or Lot Expiration Information
Lot# HD17811
Recall Number: D-1394-2012
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
02-24-2012
07-04-2012
19,039 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
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.
General area of initial distribution.
Nationwide
07-30-2013
Product Description About Product Description
Full technical description of the product.
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, Iowa 51601
Batch or Lot Expiration Information
Lot# LOT NO.1092045
