The Recall Desk
ModerateFDA (Drugs)·D-1402-2019·Announced 2019-06-19

Synthetopes Recalls Sulfur Colloid Reaction Vials Due to Processing Controls

Synthetopes Inc. is recalling Sulfur Colloid Reaction Vials nationwide due to a lack of processing controls.

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 or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Synthetopes Inc. is recalling 20 vials of Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen. The recall is being conducted because of a lack of processing controls.

The affected product is distributed nationwide. The recall includes all lots remaining within their expiry dates.

Consumers and healthcare providers should stop using the recalled product and contact Synthetopes Inc. for further instructions or a refund.

The recalled product

Product
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Manufacturer
Synthetopes Inc
Category
Drug — Biological / Diagnostic
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.

See all 8 products in this recall →

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Same hazard · processing defect

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