The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1403-2019·Announced 2019-06-19

Synthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls

Synthetopes Inc is recalling Sn-d, l-Exametazime vials nationwide due to a lack of processing controls. The FDA classifies this as a Class II recall.

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 FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Synthetopes Inc is recalling 68 vials of Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C. The recall is being conducted because of a lack of processing controls. The product is distributed nationwide.

The U.S. Food and Drug Administration has classified this recall as Class II. This classification indicates that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

All lots remaining within their expiry dates are affected by this recall. Consumers and healthcare providers should stop using the product and contact Synthetopes Inc for further instructions or a refund.

The recalled product

Product
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Manufacturer
Synthetopes Inc
Category
Drug — Pharmaceutical
Hazard
Affected units
68

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 →

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