Agency classClass IIOur severity:High FDA (Drugs)·D-0142-2018·Announced 2018-01-03

SSM St. Clare Recalls Norepinephrine IV Bags Due to Sterility Concerns

SSM St. Clare Health Center is recalling specific lots of compounded Norepinephrine IV bags in Missouri due to microbial growth detected during a routine manufacturing simulation.

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 involves a risk-of-harm product (injectable drug) where injury has not yet been reported, as the source states no distributed product was identified as containing microorganisms.

Plain-English summary

SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, is recalling specific lots of Norepinephrine 8 mg in dextrose 5% 250 mL IV bags. The recall is limited to SSM Health entities in the state of Missouri. The affected lots are identified by the following lot numbers and expiration dates: 170614-007 (9/12/2017), 170628-001 (9/26/2017), 170703-017 (10/1/2017), 170706-009 (10/4/2017), and 170719-007 (10/17/2017).

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.

This is a compounded injectable drug intended for prescription use only in hospitals or offices. Consumers and healthcare providers should check their inventory for the specific lot numbers listed above and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01
Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Category: Drug — Compounded Injectable
Hazard: microbial-contamination

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 (11)

Lot
exp: 170614-007
9/12/2017
170628-001
9/26/2017
170703-017
10/1/2017
170706-009
10/4/2017
170719-007
10/17/2017

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 · microbial contamination