Synthetopes Recalls Pentreotide Vials Due to Lack of Processing Controls
Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.
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 Pentreotide (10 uGm), Not for Direct Injection, manufactured by Synthetopes Inc. The recall involves 20 vials per package. The product was distributed nationwide.
The reason for the recall is a lack of processing controls. All lots remaining within their expiry date are included in this recall.
Consumers should stop using the product and contact Synthetopes Inc. for further instructions or a refund.
The recalled product
- Product
- Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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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