Why it was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: A24542 Exp. 02/2019; A25528 Exp. 04/2019; A27119 Exp. 05/2019; A27810 Exp. 06/2019
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0022-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Humco Holding Group, Inc
Original FDA data
Every field from FDA enforcement report D-0022-2019, exactly as published.
Show all FDA fields
- City
- Texarkana
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81061
- Address
- 7400 Alumax Rd
- Code information
- Lots: A24542 Exp. 02/2019; A25528 Exp. 04/2019; A27119 Exp. 05/2019; A27810 Exp. 06/2019
- Postal code
- 75501-0282
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0022-2019
- Classification
- Class II
- Recalling firm
- Humco Holding Group, Inc
- Product quantity
- Unknown
- Termination date
- May 7, 2020
- Reason for recall
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 28, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 12, 2018