LGM Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, because the product has inconsistent levels of active ingredients levothyroxine and liothyronine.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to inconsistent active ingredient levels rather than a high-risk pathogen or structural defect.
Plain-English summary
LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, 25kg/drum, Rx Only, manufactured by Sichuan Friendly Pharmaceutical Co., LTD. The product is identified by NDC 070870-1701-1 and is distributed nationwide in the USA.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. The affected lots are 161101 (EXP 11/2/2016), 161201 (EXP Nov 2018), 170301 (EXP Feb 2019), 170501 (Exp Apr 2019), and 170701 (Exp Jun 2019).
This is a prescription-only product. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
- Manufacturer
- LGM Pharma LLC
- Category
- Drug — Pharmaceutical Ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lots: 161101
- EXP 11/2/2016
- 161201
- EXP Nov 2018
- 170301
- EXP Feb 2019
- 170501
- Exp Apr 2019
- 170701
- Exp Jun 2019
Distribution
Distributed nationwide across the United States.
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