Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SSM Health Phenylephrine and Fentanyl Recalled for Sterility Concerns

Agency Publication Date: April 4, 2024
Share:
Sign in to monitor this recall

Summary

SSM Health Care St. Louis is recalling Phenylephrine HCl (1,000 mcg/10 mL) syringes and Fentanyl citrate (10 mcg/mL) vials used for intravenous hospital administration. Approximately 11,938 units are affected because the manufacturer did not validate the sterilization process, which means there is no assurance the drugs are actually sterile. These medications are compounded drugs intended for hospital and office use only and were distributed in Missouri.

Risk

A lack of assurance of sterility poses a serious risk to patients because contaminated intravenous medications can cause life-threatening infections. No specific injuries or illnesses have been reported to date regarding these specific lots.

What You Should Do

  1. This recall involves Phenylephrine HCl (1000 mcg/10 mL) syringes and Fentanyl citrate (10 mcg/mL) vials produced by the SSM Health Care Corporation Outsourcing Facility for hospital and office use.
  2. The recalled Phenylephrine syringes (NDC 60652-0104-1) are identified by lot numbers 20240109-837CB8, 20231219-08D09D, 20231121-20F8BB, 20231115-2FF64D, 20231101-09C52B, 20231010-3D0B35, or 20230912-847E0C.
  3. The recalled Fentanyl vials (NDC 60652-9010-1) are identified by lot number 20231031-0C91D9 with an expiration date of February 29, 2024.
  4. Stop using the recalled products immediately and contact the manufacturer or your distributor to arrange for their return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe
Variants: 1000 mcg/10 mL, Intravenous, Syringe
Lot Numbers:
20240109-837CB8 (Exp. 07-Jul-2024)
20231219-08D09D (Exp. 16-Jun-2024)
20231121-20F8BB (Exp. 19-May-2024)
20231115-2FF64D (Exp. 13-May-2024)
20231101-09C52B (Exp. 29-Apr-2024)
20231010-3D0B35 (Exp. 07-Apr-2024)
20230912-847E0C (Exp. 10-Mar-2024)
NDC:
60652-0104-1

Recall #: D-0435-2024. Quantity: 11,798 syringes.

Product: FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL)
Variants: 10 mcg/mL, 1.5 mL Total Volume, Vial, Intravenous
Lot Numbers:
20231031-0C91D9 (Exp. 29-Feb-2024)
NDC:
60652-9010-1

Recall #: D-0436-2024. Quantity: 140 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94198
Status: Active
Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Sold By: SSM Health Care; Hospitals; Medical Offices
Manufactured In: United States
Units Affected: 2 products (11,798 syringes; 140 vials)
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 ยท 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.