Synthetopes recalls Sn-DMSA solution (store frozen, not for direct injection) due to lack of processing controls. All remaining lots within expiry date.
Lack of Processing Controls.
Synthetopes is recalling Sn-DMSA solution that must be stored frozen and not used for direct injection. The recall is due to a lack of processing controls, which could affect product safety.
The product lacks proper processing controls, which may lead to unsafe conditions. This could affect the solution's safety and effectiveness for medical use.
People who own or use Sn-DMSA solution from Synthetopes Inc. Those using the product for medical purposes are most at risk.
Check for Sn-DMSA solution from Synthetopes Inc. The product must be stored frozen and not for direct injection. All remaining lots are within their expiry date.
Verify the product is Sn-DMSA solution from Synthetopes Inc. that must be stored frozen and not for direct injection.
The recall is due to a lack of processing controls, but the product is still within its expiry date. Consult your healthcare provider for safety concerns.
The official recall does not specify a remedy, so check with Synthetopes Inc. for further instructions.
The recall states a lack of processing controls, but does not specify a risk of serious injury. Consult your healthcare provider for safety concerns.
We’ve drafted a message you can send Synthetopes to request your refund or repair — edit it as you like.
Subject: Recall D-1400-2019 — Synthetopes Synthetopes Hello, I own a Synthetopes that is covered by recall D-1400-2019 from Synthetopes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
