Agency classClass IIOur severity:Severe FDA (Drugs)·D-0323-2018·Announced 2018-02-14

FDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns

The FDA is recalling sterile drug preparations made from Sufentanil Citrate Base Solution due to a lack of sterility assurance. The products were compounded by Intrathecal Compounding Specialists.

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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility assurance) is classified as Severe (Score 4), as it is not explicitly Class I but involves a significant risk of infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for all sterile drug preparations prepared from Sufentanil Citrate Base Solution. These products were compounded by Intrathecal Compounding Specialists, LLC, located in Scott, Louisiana. The recall covers all lots remaining within their expiration dates, with beyond-use dates ranging from November 15, 2017, to December 16, 2017.

The reason for the recall is a lack of sterility assurance. The affected products were dispensed between October 16, 2017, and November 17, 2017. The distribution pattern for these products is nationwide.

Healthcare providers and patients should stop using these specific preparations immediately. The FDA classifies this recall as Class II, indicating that 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.

The recalled product

Product: All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Manufacturer: Intrathecal Compounding Specialist, LLC
Category: Drug — Sterile Drug Preparations
Hazard: lack-of-sterility

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 (3)

All lots remaining within expiry (BUDs between November 15
2017 and December 16
2017).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Intrathecal Compounding Specialist, LLC 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 4 products in this recall →

Same manufacturer · Intrathecal Compounding Specialist, LLC

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Same hazard · lack of sterility