Synthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls
Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.
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, and the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature. The recall is being conducted due to a lack of processing controls. The affected product is distributed nationwide, and the recall includes all lots remaining within their expiry dates.
The source text does not specify the exact nature of the processing control failure or any specific health risks associated with the product. No illnesses or injuries have been reported in the provided text.
Consumers should stop using the product and contact Synthetopes Inc for further instructions or a refund. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Pharmaceutical Kit
- Hazard
- Affected units
- 82
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.
See all 8 products in this recall →Related recalls
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