FDA (Drugs) recall action 78678

SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled 10 products on 2018-01-03

The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2018-01-03
Critical: 0
Units: —

Why these products were recalled

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–10 of 10

ModerateFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Morphine PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.
Product
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
Category
Distribution
1 state
HighFDA (Drugs)··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.
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.
Product
Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
Category
Distribution
1 state
SevereFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
Category
Distribution
1 state
HighFDA (Drugs)··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.
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns
SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing microorganisms.
Product
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
Category
Distribution
1 state
HighFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
Category
Distribution
1 state
SevereFDA (Drugs)··2018-01-03
SSM St. Clare Recalls Oxytocin IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.
Product
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
Category
Distribution
1 state