Class I · High risk
Thyroid Tablets
Superpotent Drug
Thyroid powder
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11
Affected NDC
7807-0170-11
Compare with the code on your package — it is the most precise check available.
Drug: Thyroid Category: Thyroid Medication
- Recalling firm
- Alkano Chemicals, Inc
- NDC code
- 7807-0170-11
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0008-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Thyroid recalls
See all
Class II · Moderate risk
Thyroid
Subpotent Drug
Class II · Moderate risk
S.P Labs
Failed Stability Specifications
Class II · Moderate risk
S.P.Labs
Failed Stability Specifications
Class II · Moderate risk
Levothyroxine 25mcg in Ns 1.25ml Syringe
Lack of sterility assurance
Other cgmp deviation recalls from 2018
All cgmp deviation recalls
Class II · Moderate risk
Oxygen
CGMP Deviations
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
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