CLASS II Drug recall · Reported 3 Jan 2018 · FDA Enforcement Report
Phenylephrine 1000 mcg in 9% Sodium Chloride syringe recalled
SSM Health Care St. Louis is recalling Phenylephrine 1000 mcg in 9% Sodium Chloride syringe, Concentration: 100 mcg/mL, distributed in Missouri. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0144-2018
- FDA event ID
- 78678
- Recalling firm
- SSM Health Care St. Louis, Fenton, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2017
- FDA classified
- 28 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 10 Aug 2017 | Recall initiated by company | |
| 28 Dec 2017 | Classified by FDA | +140 days |
| 3 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
SSM Health entities in the state of MO only
Questions about this recall
Is Phenylephrine 1000 mcg in 9% Sodium Chloride syringe, Concentration: 100 mcg/mL recalled?
Yes. SSM Health Care St. Louis recalled Phenylephrine 1000 mcg in 9% Sodium Chloride syringe, Concentration: 100 mcg/mL on 10 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-0144-2018.
Why was it 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 lots are affected?
Lot, exp: 170622-007, 9/20/2017; 170710-007, 10/8/2017
Where was it sold?
SSM Health entities in the state of MO only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.