Synthetopes Recalls Sn-Tetrofosmin Kits Due to Processing Control Deficiencies
Synthetopes Inc is recalling Sn-Tetrofosmin Kits nationwide due to a lack of processing controls. All lots remaining within their expiry date are affected.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when specific injury reports are not detailed but the classification indicates a temporary or medically reversible adverse health consequence.
Plain-English summary
Synthetopes Inc is voluntarily recalling Sn-Tetrofosmin Kit 5.0 mL products nationwide. The recall is being conducted because of a lack of processing controls during the manufacturing process.
The affected product is the Sn-Tetrofosmin Kit 5.0 mL, which is labeled to be thawed and vented before use and is not for direct injection. The product must be stored frozen. All lots remaining within their expiry date are included in this recall.
This recall is classified as Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries have been reported in the source text. Healthcare providers and patients should stop using the affected product and contact Synthetopes Inc for further instructions.
The recalled product
- Product
- Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
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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