Medications & Supplements/Prescription Drugs

PharMEDium Services, LLC: Hydromorphone HCl Syringes Recalled for Incorrect Potency Levels

Agency Publication Date: June 8, 2018

Summary

PharMEDium Services, LLC is recalling 2,800 syringes of HYDROmorphone HCl (hydromorphone) 0.5 mg per mL in 0.9% Sodium Chloride due to the medication being either superpotent or subpotent. This means the syringes may contain significantly more or less of the active pain medication than what is listed on the label, which can lead to serious health complications. These prescription products were distributed in 1 mL total volumes within 3 mL syringes to healthcare facilities nationwide between June and July 2018.

Risk

Incorrect dosage of hydromorphone, a powerful opioid, can lead to respiratory depression or overdose if the product is superpotent, or inadequate pain management and withdrawal symptoms if the product is subpotent. Either condition poses a significant risk to patient safety in a clinical setting.

What You Should Do

Identify your product by checking for 'HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride' in 3 mL syringes (1 mL total volume).
Check the packaging for Lot numbers 180820005D (Expiration 6/21/2018), 180990007D (Expiration 7/8/2018), or 181000020D (Expiration 7/9/2018).
Immediately stop using any syringes from the affected lots and secure them to prevent further administration to patients.
Contact your healthcare provider or pharmacist for guidance regarding any previous use of these specific lots.
Return any unused product to the place of purchase for a refund and contact PharMEDium Services, LLC at 36 Stults Rd, Dayton, New Jersey for further instructions.
For additional information 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

Drug potency issue remedy

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

Affected Products

Product: HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe

Model:

Recall #: D-0854-2018

Lot Numbers:

180820005D (Exp 6/21/2018)

180990007D (Exp 7/8/2018)

181000020D (Exp 7/9/2018)

Date Ranges: 6/21/2018, 7/8/2018, 7/9/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80251

Status: Resolved

Manufacturer: PharMEDium Services, LLC

Sold By: hospitals; healthcare facilities

Manufactured In: United States

Units Affected: 2,800 syringes

Distributed To: Nationwide

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

Identify your product by checking for 'HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride' in 3 mL syringes (1 mL total volume).

Check the packaging for Lot numbers 180820005D (Expiration 6/21/2018), 180990007D (Expiration 7/8/2018), or 181000020D (Expiration 7/9/2018).

Immediately stop using any syringes from the affected lots and secure them to prevent further administration to patients.

Contact your healthcare provider or pharmacist for guidance regarding any previous use of these specific lots.

Return any unused product to the place of purchase for a refund and contact PharMEDium Services, LLC at 36 Stults Rd, Dayton, New Jersey for further instructions.

For additional information 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.