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
Reported: January 3, 2018 Initiated: August 10, 2017 #D-0144-2018
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Units Affected
- N/A
- Distribution
- SSM Health entities in the state of MO only
- Location
- Fenton, MO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2018. Severity: Moderate. Recall number: D-0144-2018.
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