Synthetopes Recalls Sn-DMSA Solution Due to Processing Control Deficiencies
Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a temporary or medically reversible adverse health consequence. The source text cites a lack of processing controls but does not report specific injuries or illnesses, aligning with a moderate severity assessment for a drug recall without confirmed harm.
Plain-English summary
Synthetopes Inc. is recalling Sn-DMSA solution, Store Frozen, Not for Direct Injection. The recall is being conducted due to a lack of processing controls. The affected product consists of 3 vials per unit.
The recall covers all lots remaining within their expiry date. The product was distributed nationwide. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers should stop using the product and contact Synthetopes Inc. for further instructions. The product is labeled as not for direct injection.
The recalled product
- Product
- Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
- Affected units
- 3
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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