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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81128

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 22, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Syntec Pharma Corp

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0013-2019
Recall number
D-0013-2019
Initiated
August 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Syntec Pharma Corp
Quantity
2 drums

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots

Distribution pattern

Al & TX only

drug · product 2 of 2

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 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0

D-0014-2019
Recall number
D-0014-2019
Initiated
August 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Syntec Pharma Corp
Quantity
486 kg

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots

Distribution pattern

Al & TX only