Unrated Drug recall · FDA · Published May 28, 2019

Synthetopes Sn-d,l-Exametazime Recall: Lack of Processing Controls Hazard

Synthetopes recalls Sn-d,l-Exametazime (not for direct injection) due to lack of processing controls. All remaining lots within expiry date are affected. No specific remedy provided in official notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1403-2019Drug Synthetopes ›

Recall notice

Lack of Processing Controls.

Take action

Contact the company

Recalling firmSynthetopes Inc216 Earnhardt St · Conway, SC 29526-8287

✎ GovInfoNow plain-language explainer

Synthet:opes is recalling Sn-d,l-Exametazime (not for direct injection) because of lack of processing controls. This could affect product safety, though the recall covers all lots still within their expiry date. Read more at govinfonow.com/recall/38744-synthetopes-sn-d-l-exametazime-recall-lack-of-processing-controls.

Source Summary by GovInfoNow · govinfonow.com/recall/38744-synthetopes-sn-d-l-exametazime-recall-lack-of-processing-controls · Updated October 5, 2026 · FDA enforcement record: FDA #D-1403-2019

Cite this page

“Synthetopes Sn-d,l-Exametazime Recall: Lack of Processing Controls Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38744-synthetopes-sn-d-l-exametazime-recall-lack-of-processing-controls. Based on FDA recall #D-1403-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1403-2019%22&limit=1).

Synthetopes Inc voluntarily recalled Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C on May 28, 2019, due to a lack of processing controls, the FDA said. The recall involves 68 vials distributed nationwide.

How to tell if you have it

Brand: Synthetopes
Product: Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C
Quantity: 68 vials

The hazard

The product was recalled due to a lack of processing controls. The FDA classified the recall as Class II.

Context

GovInfoNow's records show other recent recalls include Shoolin Pharma Chem Sildenafil Recall: FDA Inspection Findings (2026-08-03) and Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk (2026-01-21). Another recent recall of a similar product is Shoolin Pharma Chem Tadalafil Recall: FDA Inspection Findings (2026-08-03).

How to tell if you have this one

Check for the product name 'Sn-d,l-Exametazime (not for direct injection)' on the label. All lots within their expiry date are included in this recall.

Brand
Synthetopes
Category
Drug

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide.

Recall number	Product, codes & lots	Quantity
D-1399-2019	Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.; All lots remaining within expiry.	20 vials
D-1400-2019	Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.; All lots remaining within expiry.	3 vials
D-1401-2019	Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.; All lots remaining within expiry.	35 vials
D-1402-2019	Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.; All lots remaining within expiry.	20 vials
D-1403-2019	Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.; All lots remaining within expiry.	68 vials
D-1404-2019	Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.; All lots remaining within expiry.	82 vials
D-1405-2019	Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.; All lots remaining within expiry.	Unknown
D-1406-2019	Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.; All lots remaining within expiry.	45 vials

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and expiry date on the label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

May 28, 2019Firm started the recall
Jun 19, 2019Published in FDA’s Enforcement Report
Jun 20, 2019FDA classified it Class II
Oct 15, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/38744-synthetopes-sn-d-l-exametazime-recall-lack-of-processing-controls">Synthetopes Sn-d,l-Exametazime Recall: Lack of Processing Controls Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1403-2019 (May 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1403-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.