Synthetopes Recalls Sn-Mertiatide Kit Due to Processing Control Deficiencies
Synthetopes Inc is recalling Sn-Mertiatide Kits nationwide due to a lack of processing controls. The recall covers all lots remaining within their expiry date.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthetopes Inc is voluntarily recalling Sn-Mertiatide Kits, 1 milligram betiatide, Not for Direct Injection, Store at Room Temperature. The recall is being conducted due to a lack of processing controls. The affected product consists of 35 vials per kit.
The recall covers all lots remaining within their expiry date. The product was distributed nationwide. No specific lot numbers or dates are provided in the source text.
Consumers should stop using the product and contact Synthetopes Inc for further instructions or a refund. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Diagnostic Reagent
- Hazard
- Affected units
- 35
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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