Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.
What this means for you
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP, a 25 kg bag active pharmaceutical ingredient intended for prescription compounding only. The product was manufactured by Sichuan Friendly Pharmaceutical Co., Ltd. in China and distributed by Syntec Pharma Corp in Farmingdale, New York.
The recall was initiated after the supplier reported CGMP deviations, specifically that the Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. The labeled range for levothyroxine is 34.2-41.8mcg/grain, and for liothyronine is 8.1-9.9mcg/grain. The recall covers all lots of the product.
The affected product was distributed only to Alabama and Texas. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hon
- Manufacturer
- Syntec Pharma Corp
- 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 (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Syntec Pharma Corp under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Syntec Pharma Corp
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FDA (Drugs) · 2018-10-17
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FDA (Drugs) · 2018-10-10