Synthetopes recalls 11.9 mg sodium pyrophosphate kits (not for direct injection) due to lack of processing controls. All remaining lots within expiry date.
Lack of Processing Controls.
Synthet:opes is recalling its 11.9 mg sodium pyrophosphate kits (not for direct injection) because of insufficient processing controls. This could pose a risk to users if the product is used improperly.
The product lacks proper processing controls, which could lead to improper formulation or contamination. This may affect the product's safety and effectiveness when used as intended.
Users of the Sn-Pyrophosphate Kit (11.9 mg sodium pyrophosphate) not for direct injection. Those who have the product and follow the storage instructions (room temperature) are most at risk.
Check for the product name 'Sn-Pyrophosphate Kit', 11.9 mg sodium pyrophosphate, and the manufacturer 'Synthetopes Inc'. The product is not for direct injection and should be stored at room temperature.
Identify if you have the Sn-Pyrophosphate Kit (11.9 mg sodium pyrophosphate) from Synthetopes Inc, not for direct injection.
The recall states there is a lack of processing controls, but the product is not for direct injection and should be stored at room temperature. Safety details are not specified in the recall.
Look for the product name 'Sn-Pyrophosphate Kit', 11.9 mg sodium pyrophosphate, and the manufacturer 'Synthetopes Inc'. The product is not for direct injection and should be stored at room temperature.
The recall does not specify a remedy, so no action is required based on the official notice.
We’ve drafted a message you can send Synthetopes to request your refund or repair — edit it as you like.
Subject: Recall D-1406-2019 — Synthetopes Synthetopes Hello, I own a Synthetopes that is covered by recall D-1406-2019 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.
