Class II
Terminated
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
This recall has been terminated (originally issued January 3, 2018).
- Recall Initiated
- August 10, 2017
- Posted
- January 3, 2018
- Recall Number
- D-0144-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Fenton, MO, United States
- Official Source
- View on FDA website ↗
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.
Distribution
SSM Health entities in the state of MO only
Lot / Code Info
Lot, exp: 170622-007, 9/20/2017; 170710-007, 10/8/2017
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