Medications & Supplements/Prescription Drugs

SSM Health Care Hydromorphone Syringes Recalled for Quality Control Issues

Agency Publication Date: May 31, 2023

Summary

SSM Health Care St. Louis is recalling 3,232 syringes of Hydromorphone HCl (10 mg in 0.9% Sodium Chloride, 50 mL). The manufacturer discontinued its quality program, which means it can no longer guarantee the medication meets the required standards for strength, purity, and quality. This medication is a prescription opioid pain reliever used in clinical settings.

Risk

Because the quality program was discontinued, there is a risk that the medication may not contain the correct dose or could have purity issues. This could result in patients receiving ineffective pain management or suffering adverse reactions from potentially contaminated or improperly formulated medication.

What You Should Do

This recall affects Hydromorphone HCl 10 mg in 0.9% Sodium Chloride, 50 mL syringes (0.2 mg/mL) sold under the SSM Health Care Corporation brand with NDC 60652-0600-2.
Check your clinical supply for the following lot numbers and Beyond Use Dates (BUD): 20230222-45AB24 (BUD: 8/21/2023), 20230110-058361 (BUD: 7/9/2023), 20221208-0F5483 (BUD: 6/6/2023), 20221109-45BA60 (BUD: 5/8/2023), 20220929-523FD5 (BUD: 3/28/2023), 20220914-5D5AE0 (BUD: 3/13/2023), 220502-024 (BUD: 10/29/2022), 220510-035 (BUD: 11/6/2022), 220526-015 (BUD: 11/22/2022), and 220811-010 (BUD: 2/7/2023).
Stop using the recalled product immediately. Contact the manufacturer, SSM St. Clare Health Center, or your distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge (50 mL syringe)by SSM Health Care Corporation

Variants: 0.2 mg/mL, Rx Only

Lot Numbers:

20230222-45AB24 (BUD: 8/21/2023)

20230110-058361 (BUD: 7/9/2023)

20221208-0F5483 (BUD: 6/6/2023)

20221109-45BA60 (BUD: 5/8/2023)

20220929-523FD5 (BUD: 3/28/2023)

20220914-5D5AE0 (BUD: 3/13/2023)

220502-024 (BUD: 10/29/2022)

220510-035 (BUD: 11/6/2022)

220526-015 (BUD: 11/22/2022)

220811-010 (BUD: 2/7/2023)

NDC:

60652-0600-2

Product manufactured at SSM Health Care Corporation Outsourcing Facility in Fenton, MO.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92395

Status: Active

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

Sold By: SSM Health Care Corporation; Hospitals; Infusion Centers

Manufactured In: United States

Units Affected: 3,232 syringes

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

Risk

What You Should Do

This recall affects Hydromorphone HCl 10 mg in 0.9% Sodium Chloride, 50 mL syringes (0.2 mg/mL) sold under the SSM Health Care Corporation brand with NDC 60652-0600-2.

Check your clinical supply for the following lot numbers and Beyond Use Dates (BUD): 20230222-45AB24 (BUD: 8/21/2023), 20230110-058361 (BUD: 7/9/2023), 20221208-0F5483 (BUD: 6/6/2023), 20221109-45BA60 (BUD: 5/8/2023), 20220929-523FD5 (BUD: 3/28/2023), 20220914-5D5AE0 (BUD: 3/13/2023), 220502-024 (BUD: 10/29/2022), 220510-035 (BUD: 11/6/2022), 220526-015 (BUD: 11/22/2022), and 220811-010 (BUD: 2/7/2023).

Stop using the recalled product immediately. Contact the manufacturer, SSM St. Clare Health Center, or your distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge (50 mL syringe)by SSM Health Care Corporation

Variants: 0.2 mg/mL, Rx Only

Lot Numbers:

20230222-45AB24 (BUD: 8/21/2023)

20230110-058361 (BUD: 7/9/2023)

20221208-0F5483 (BUD: 6/6/2023)

20221109-45BA60 (BUD: 5/8/2023)

20220929-523FD5 (BUD: 3/28/2023)

20220914-5D5AE0 (BUD: 3/13/2023)

220502-024 (BUD: 10/29/2022)

220510-035 (BUD: 11/6/2022)

220526-015 (BUD: 11/22/2022)

220811-010 (BUD: 2/7/2023)

NDC:

60652-0600-2

Product manufactured at SSM Health Care Corporation Outsourcing Facility in Fenton, MO.