Agency classClass IIOur severity:High FDA (Drugs)·D-0138-2018·Announced 2018-01-03

SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags

SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (lack of sterility assurance) where injury has not yet been reported, as no distributed product was found to contain microorganisms.

Plain-English summary

SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling specific lots of Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL bags. The product is a compounded injectable drug intended for prescription use in hospitals and offices. The affected lots are 170621-008, 170703-002, and 170711-031, with expiration dates ranging from September 19, 2017, to October 9, 2017.

The recall was initiated due to a lack of sterility assurance. Microbial growth was detected during a routine simulation of the manufacturing process. The source text explicitly states that no batches of distributed product have been identified as actually containing microorganisms.

The product was distributed to SSM Health entities in the state of Missouri only. Because this is a prescription injectable drug for hospital and office use, consumers are unlikely to possess this product directly. Healthcare facilities should discontinue use of the affected lots and contact the recalling firm for further instructions.

The recalled product

Product: Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
microbial-growth

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 (7)

Lot
exp: 170621-008
09/19/2017
170703-002
10/01/2017
170711-031
10/09/2017

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 10 recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center 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 10 products in this recall →

Same manufacturer · SSM Health Care St. Louis DBA SSM St. Clare Health Center

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Same hazard · lack of sterility