Medications & Supplements/Prescription Drugs

SSM Health Care St. Louis DBA SSM St. Clare Health Center: Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: December 28, 2017

Summary

SSM Health Care St. Louis is recalling 10 different types of compounded injectable medications, including pain relievers like Fentanyl, Morphine, and Hydromorphone, because microbial growth was detected during a routine test of the manufacturing process. While no specific contaminated batches have been identified in the field, the lack of sterility assurance poses a significant risk for patients receiving these intravenous or injectable drugs. These products were distributed exclusively to SSM Health entities within the state of Missouri for hospital and office use.

Risk

If an injectable drug is not sterile, it can introduce bacteria or other microorganisms directly into a patient's bloodstream or tissue, potentially causing serious or life-threatening infections. No injuries or actual contamination in distributed products have been reported to date.

What You Should Do

Immediately check your facility's inventory for the affected injectable medications, including Fentanyl, Amiodarone, Hydromorphone, Morphine, Neostigmine, Norepinephrine, Oxytocin, Phenylephrine, and Succinylcholine.
Verify the Lot numbers and expiration dates against the affected list, specifically looking for codes such as Fentanyl 10 mcg/mL Lot 170614-006 (Exp 9/12/2017) or Morphine 50 mg/5 mL Lots 170627-012 (Exp 9/25/2017) and 170629-019 (Exp 9/27/2017).
Stop using any affected product immediately and quarantine it to prevent use in patients.
Contact your healthcare provider or pharmacist immediately if you have received any of these medications and are concerned about your health.
Return any unused product to the SSM St. Clare Outsourcing Facility pharmacy for a refund and further instructions.
For additional information, contact the manufacturer or the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist; return unused product for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fentanyl 10 mcg in 0.9% Sodium Chloride (1 mL Vial)

Model:

NDC: 88890-9010-81

Lot Numbers:

170614-006 (Exp 9/12/2017)

Product: Amiodarone 900 mg in dextrose 5% (500 mL bag)

Model:

NDC: 88890-0333-01

Lot Numbers:

170711-005 (Exp 10/09/2017)

Product: Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride (150 mL bag)

Model:

NDC: 88883-4272-01

Lot Numbers:

170621-008 (Exp 09/19/2017)

170703-002 (Exp 10/01/2017)

170711-031 (Exp 10/09/2017)

Product: HYDROmorphone 10 mg in 0.9% Sodium Chloride PCA (50 mL Cartridge)

Model:

NDC: 88883-0600-01

Lot Numbers:

170615-004 (Exp 9/13/2017)

170720-009 (Exp 10/18/2017)

Product: Morphine 50 mg in 0.9% Sodium Chloride PCA (50 mL Cartridge)

Model:

NDC: 88887-6795-01

Lot Numbers:

170627-012 (Exp 9/25/2017)

170629-019 (Exp 9/27/2017)

Product: Neostigmine Methylsulfate 5 mg/5 mL (5 mL Syringe)

Model:

NDC: 88890-0329-01

Lot Numbers:

170705-002 (Exp 10/03/2017)

Product: Norepinephrine 8 mg in dextrose 5% (250 mL IV Bag)

Model:

NDC: 88890-0334-01

Lot Numbers:

170614-007 (Exp 9/12/2017)

170628-001 (Exp 9/26/2017)

170703-017 (Exp 10/1/2017)

170706-009 (Exp 10/4/2017)

170719-007 (Exp 10/17/2017)

Product: Oxytocin 30 units in 0.9% Sodium Chloride (500 mL IV Bag)

Model:

NDC: 88890-0903-01

Lot Numbers:

170619-011 (Exp 9/17/2017)

170707-007 (Exp 10/5/2017)

170713-009 (Exp 10/11/2017)

Product: Phenylephrine 1000 mcg in 0.9% Sodium Chloride (10 mL syringe)

Model:

NDC: 88890-0104-01

Lot Numbers:

170622-007 (Exp 9/20/2017)

170710-007 (Exp 10/8/2017)

Product: Succinylcholine chloride 100 mg (5 mL syringe)

Model:

NDC: 88890-7536-01

Lot Numbers:

170620-005 (Exp 9/18/2017)

170626-003 (Exp 9/24/2017)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78678

Status: Resolved

Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center

Sold By: SSM Health entities

Manufactured In: United States

Distributed To: Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your facility's inventory for the affected injectable medications, including Fentanyl, Amiodarone, Hydromorphone, Morphine, Neostigmine, Norepinephrine, Oxytocin, Phenylephrine, and Succinylcholine.

Verify the Lot numbers and expiration dates against the affected list, specifically looking for codes such as Fentanyl 10 mcg/mL Lot 170614-006 (Exp 9/12/2017) or Morphine 50 mg/5 mL Lots 170627-012 (Exp 9/25/2017) and 170629-019 (Exp 9/27/2017).

Stop using any affected product immediately and quarantine it to prevent use in patients.

Contact your healthcare provider or pharmacist immediately if you have received any of these medications and are concerned about your health.

Return any unused product to the SSM St. Clare Outsourcing Facility pharmacy for a refund and further instructions.

For additional information, contact the manufacturer or the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Fentanyl 10 mcg in 0.9% Sodium Chloride (1 mL Vial)

Model:

NDC: 88890-9010-81

Lot Numbers:

170614-006 (Exp 9/12/2017)

Product: Amiodarone 900 mg in dextrose 5% (500 mL bag)

Model:

NDC: 88890-0333-01

Lot Numbers:

170711-005 (Exp 10/09/2017)

Product: Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride (150 mL bag)

Model:

NDC: 88883-4272-01

Lot Numbers:

170621-008 (Exp 09/19/2017)

170703-002 (Exp 10/01/2017)

170711-031 (Exp 10/09/2017)

Product: HYDROmorphone 10 mg in 0.9% Sodium Chloride PCA (50 mL Cartridge)

Model:

NDC: 88883-0600-01

Lot Numbers:

170615-004 (Exp 9/13/2017)

170720-009 (Exp 10/18/2017)

Product: Morphine 50 mg in 0.9% Sodium Chloride PCA (50 mL Cartridge)

Model:

NDC: 88887-6795-01

Lot Numbers:

170627-012 (Exp 9/25/2017)

170629-019 (Exp 9/27/2017)

Product: Neostigmine Methylsulfate 5 mg/5 mL (5 mL Syringe)

Model:

NDC: 88890-0329-01

Lot Numbers:

170705-002 (Exp 10/03/2017)

Product: Norepinephrine 8 mg in dextrose 5% (250 mL IV Bag)

Model:

NDC: 88890-0334-01

Lot Numbers:

170614-007 (Exp 9/12/2017)

170628-001 (Exp 9/26/2017)

170703-017 (Exp 10/1/2017)

170706-009 (Exp 10/4/2017)

170719-007 (Exp 10/17/2017)

Product: Oxytocin 30 units in 0.9% Sodium Chloride (500 mL IV Bag)

Model:

NDC: 88890-0903-01

Lot Numbers:

170619-011 (Exp 9/17/2017)

170707-007 (Exp 10/5/2017)

170713-009 (Exp 10/11/2017)

Product: Phenylephrine 1000 mcg in 0.9% Sodium Chloride (10 mL syringe)

Model:

NDC: 88890-0104-01

Lot Numbers:

170622-007 (Exp 9/20/2017)

170710-007 (Exp 10/8/2017)

Product: Succinylcholine chloride 100 mg (5 mL syringe)

Model:

NDC: 88890-7536-01

Lot Numbers:

170620-005 (Exp 9/18/2017)

170626-003 (Exp 9/24/2017)