Synthetopes Recalls Sn-Pyrophosphate Kits Due to Processing Control Issues
Synthetopes Inc. is recalling Sn-Pyrophosphate Kits because of a lack of processing controls. The recall covers all lots remaining within their expiry dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific hazard is a lack of processing controls, which is a quality issue without reported injuries.
Plain-English summary
Synthetopes Inc. is recalling Sn-Pyrophosphate Kits, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature. The recall was initiated due to a lack of processing controls.
The affected product consists of 45 vials. The recall includes all lots remaining within their expiry dates. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Synthetopes Inc. for further instructions or a refund.
The recalled product
- Product
- Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Pharmaceuticals
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Synthetopes Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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