Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Injectable Pain Medications Recalled for Incorrect or Missing Labeling

Agency Publication Date: December 22, 2017

Summary

Pharmedium Services is recalling specific lots of compounded Morphine Sulfate and Hydromorphone HCl injections because the labels are missing or contain incorrect lot numbers and expiration dates. This recall affects various dosage strengths and volumes of these medications, which are intended for intravenous (IV) use and are prescription-only. These products were compounded at the PharMEDium Services facility in Cleveland, Mississippi, and distributed to healthcare facilities nationwide.

Risk

Incorrect or missing labeling information, such as expiration dates and lot numbers, can lead to the use of medication beyond its intended shelf life or prevent hospitals from identifying specific products during a safety event. This poses a risk of administering medication that may not meet quality standards.

What You Should Do

Check your medical supplies for morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg/mL or 2 mg/mL) and HYDROmorphone HCl in 0.9% Sodium Chloride Injection (1 mg/mL).
Verify if your product matches the affected lot numbers and expiration dates: Morphine 1 mg/mL (Lot 172360026C, Exp 11/23/2017), Morphine 2 mg/mL (Lot 172410028C, Exp 11/28/2017 and Lot 172470030C, Exp 12/04/2017), or Hydromorphone 1 mg/mL (Lot 172410025C, Exp 11/27/2017).
Contact your healthcare provider or pharmacist immediately for guidance if you have been administered these products or have them in your possession.
Return any unused product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC at 150 N Field Dr Ste 350, Lake Forest, Illinois for further instructions.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return.

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

Affected Products

Product: morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL)

Model:

NDC# 61553-259-28

Recall #: D-0130-2018

Lot Numbers:

172360026C (Exp. 11/23/2017)

Date Ranges: 11/23/2017

Product: morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL

Model:

NDC# 61553-455-78

Recall #: D-0131-2018

Lot Numbers:

172410028C (Exp. 11/28/2017)

172470030C (Exp. 12/04/2017)

Date Ranges: 11/28/2017, 12/04/2017

Product: HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL

Model:

NDC# 61553-165-78

Recall #: D-0132-2018

Lot Numbers:

172410025C (Exp. 11/27/2017)

Date Ranges: 11/27/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78694

Status: Resolved

Manufacturer: Pharmedium Services, LLC

Sold By: Hospitals; Healthcare facilities

Manufactured In: United States

Units Affected: 3 products (Unknown; Unknown; Unknown)

Distributed To: Nationwide

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

Check your medical supplies for morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg/mL or 2 mg/mL) and HYDROmorphone HCl in 0.9% Sodium Chloride Injection (1 mg/mL).

Verify if your product matches the affected lot numbers and expiration dates: Morphine 1 mg/mL (Lot 172360026C, Exp 11/23/2017), Morphine 2 mg/mL (Lot 172410028C, Exp 11/28/2017 and Lot 172470030C, Exp 12/04/2017), or Hydromorphone 1 mg/mL (Lot 172410025C, Exp 11/27/2017).

Contact your healthcare provider or pharmacist immediately for guidance if you have been administered these products or have them in your possession.

Return any unused product to the pharmacy or place of purchase for a refund and contact Pharmedium Services, LLC at 150 N Field Dr Ste 350, Lake Forest, Illinois for further instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL)

Model:

NDC# 61553-259-28

Recall #: D-0130-2018

Lot Numbers:

172360026C (Exp. 11/23/2017)

Date Ranges: 11/23/2017

Product: morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL

Model:

NDC# 61553-455-78

Recall #: D-0131-2018

Lot Numbers:

172410028C (Exp. 11/28/2017)

172470030C (Exp. 12/04/2017)

Date Ranges: 11/28/2017, 12/04/2017

Product: HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL

Model:

NDC# 61553-165-78

Recall #: D-0132-2018

Lot Numbers:

172410025C (Exp. 11/27/2017)

Date Ranges: 11/27/2017