Multi-event August 2018 FDA Recall Drug by Humco Holding Group, Inc
This Multi-event Class II drug recall was voluntarily initiated by Humco Holding Group, Inc on August 28, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0024-2019
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
08-28-2018
10-24-2018
10 kilograms
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.
Humco Holding Group, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
Batch or Lot Expiration Information
Lot# Lot: A26450 Exp. 05/2019
Recall Number: D-0022-2019
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
08-28-2018
10-24-2018
Unknown
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.
Humco Holding Group, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501
Batch or Lot Expiration Information
Lot# Lots: A24542 Exp. 02/2019; A25528 Exp. 04/2019; A27119 Exp. 05/2019; A27810 Exp. 06/2019
Recall Number: D-0023-2019
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
08-28-2018
10-24-2018
Unknown.
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.
Humco Holding Group, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
Batch or Lot Expiration Information
Lot# Lots: A24543 Exp. 02/2019; A25724 Exp. 01/2019; A25529 Exp. 04/2019; A25723 Exp. 04/2019; A27120 Exp. 05/2019; A27811 Exp. 06/2019; A28626 Exp. 06/2019; A29171 Exp. 06/2019; A29221 Exp. 06/2019
