Recall record at a glance
| Official record | D-0013-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Syntec Pharma Corp |
| Report date | Oct 17, 2018 |
| Recall initiation date | Aug 22, 2018 |
| Quantity | 2 drums |
| Location | Farmingdale, NY, United States |
Official product description
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., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0
Why the product was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Distribution information
Al & TX only
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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