The Recall Desk

FDA (Drugs) recall action 81128

Syntec Pharma Corp recalled 2 products on 2018-10-17

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-10-17
Critical
0
Units
2

Why these products were recalled

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2018-10-17

    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.

    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
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2018-10-17

    Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Syntec Pharma Corp is recalling 5 KG bags of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

    Product
    THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd
    Category
    Distribution
    2 states