Medications & Supplements/Prescription Drugs

PharMEDium Services, LLC: Hydromorphone HCl Syringes Recalled for Undeclared Sulfites

Agency Publication Date: June 28, 2019

Summary

PharMEDium Services, LLC is recalling 28,140 syringes of Hydromorphone HCl in 0.9% sodium chloride (0.5mg per mL, 1 mL in 3mL syringe). While the company's customer resource center stated the product was sulfite-free, it was actually produced using a raw material that contains sulfites. This recall affects various lots distributed nationwide with expiration dates ranging from June to August 2019.

Risk

Patients with a sulfite sensitivity or allergy may experience a serious or life-threatening allergic reaction, including anaphylaxis or severe asthma attacks, if they are administered this medication.

What You Should Do

Check your medication supply for Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringes (NDC 61553-352-78) labeled as PharMEDium Services.
Verify if your product matches any of the following lot numbers and expiration dates: 190670030D, 190670031D, 190670032D, 190670033D (Exp. 6/9/2019); 190710015D, 190710016D, 190710017D, 190710018D, 190710019D (Exp. 6/11/2019); 190730028D, 190730029D, 190730030D (Exp. 6/13/2019); 190740018D (Exp. 6/16/2019); 190770028D, 190770029D (Exp. 6/17/2019); 190780027D, 190780028D, 190780029D (Exp. 6/18/2019); 190790030D (Exp. 6/19/2019); 190800012D, 190800013D, 190800014D, 190800015D, 190800016D (Exp. 6/20/2019); 190810033D, 190810034D, 190810035D, 190810036D (Exp. 6/23/2019); 190840002D (Exp. 6/24/2019); 190870008D (Exp. 6/27/2019); 190910015D (Exp. 7/1/2019); 190980033D (Exp. 7/8/2019); 190990017D, 190990030D (Exp. 7/9/2019); 191000035D (Exp. 7/10/2019); 191010008D, 191010009D, 191010010D (Exp. 7/11/2019); 191050002D (Exp. 7/15/2019); 191120002D (Exp. 7/22/2019); 191160001D (Exp. 7/28/2019); 191210020D, 191210021D, 191210022D (Exp. 7/31/2019); 191220017D (Exp. 8/1/2019).
Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or have it in your possession, especially if you have a known sulfite allergy.
Return any unused syringes to the pharmacy or place of purchase for a refund and contact PharMEDium Services, LLC at 800-523-7749 for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Medication recall for incorrect formulation.

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 in 0.9% sodium chloride (1 mL in 3mL syringe)

Model:

NDC 61553-352-78

Lot Numbers:

190670030D (Exp. 6/9/2019)

190670031D (Exp. 6/9/2019)

190670032D (Exp. 6/9/2019)

190670033D (Exp. 6/9/2019)

190710015D (Exp. 6/11/2019)

190710016D (Exp. 6/11/2019)

190710017D (Exp. 6/11/2019)

190710018D (Exp. 6/11/2019)

190710019D (Exp. 6/11/2019)

190730028D (Exp. 6/13/2019)

190730029D (Exp. 6/13/2019)

190730030D (Exp. 6/13/2019)

190740018D (Exp. 6/16/2019)

190770028D (Exp. 6/17/2019)

190770029D (Exp. 6/17/2019)

190780027D (Exp. 6/18/2019)

190780028D (Exp. 6/18/2019)

190780029D (Exp. 6/18/2019)

190790030D (Exp. 6/19/2019)

190800012D (Exp. 6/20/2019)

190800013D (Exp. 6/20/2019)

190800014D (Exp. 6/20/2019)

190800015D (Exp. 6/20/2019)

190800016D (Exp. 6/20/2019)

190810033D (Exp. 6/23/2019)

190810034D (Exp. 6/23/2019)

190810035D (Exp. 6/23/2019)

190810036D (Exp. 6/23/2019)

190840002D (Exp. 6/24/2019)

190870008D (Exp. 6/27/2019)

190910015D (Exp. 7/1/2019)

190980033D (Exp. 7/8/2019)

190990017D (Exp. 7/9/2019)

190990030D (Exp. 7/9/2019)

191000035D (Exp. 7/10/2019)

191010008D (Exp. 7/11/2019)

191010009D (Exp. 7/11/2019)

191010010D (Exp. 7/11/2019)

191050002D (Exp. 7/15/2019)

191120002D (Exp. 7/22/2019)

191160001D (Exp. 7/28/2019)

191210020D (Exp. 7/31/2019)

191210021D (Exp. 7/31/2019)

191210022D (Exp. 7/31/2019)

191220017D (Exp. 8/1/2019)

Date Ranges: Exp. 6/9/2019 - 8/1/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83207

Status: Resolved

Manufacturer: PharMEDium Services, LLC

Sold By: Hospitals; Healthcare facilities

Manufactured In: United States

Units Affected: 28,140 syringes

Distributed To: Nationwide

Agency Last Updated: July 16, 2019

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

Check your medication supply for Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringes (NDC 61553-352-78) labeled as PharMEDium Services.

Verify if your product matches any of the following lot numbers and expiration dates: 190670030D, 190670031D, 190670032D, 190670033D (Exp. 6/9/2019); 190710015D, 190710016D, 190710017D, 190710018D, 190710019D (Exp. 6/11/2019); 190730028D, 190730029D, 190730030D (Exp. 6/13/2019); 190740018D (Exp. 6/16/2019); 190770028D, 190770029D (Exp. 6/17/2019); 190780027D, 190780028D, 190780029D (Exp. 6/18/2019); 190790030D (Exp. 6/19/2019); 190800012D, 190800013D, 190800014D, 190800015D, 190800016D (Exp. 6/20/2019); 190810033D, 190810034D, 190810035D, 190810036D (Exp. 6/23/2019); 190840002D (Exp. 6/24/2019); 190870008D (Exp. 6/27/2019); 190910015D (Exp. 7/1/2019); 190980033D (Exp. 7/8/2019); 190990017D, 190990030D (Exp. 7/9/2019); 191000035D (Exp. 7/10/2019); 191010008D, 191010009D, 191010010D (Exp. 7/11/2019); 191050002D (Exp. 7/15/2019); 191120002D (Exp. 7/22/2019); 191160001D (Exp. 7/28/2019); 191210020D, 191210021D, 191210022D (Exp. 7/31/2019); 191220017D (Exp. 8/1/2019).

Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or have it in your possession, especially if you have a known sulfite allergy.

Return any unused syringes to the pharmacy or place of purchase for a refund and contact PharMEDium Services, LLC at 800-523-7749 for further instructions.

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

Affected Products

Product: Hydromorphone HCl in 0.9% sodium chloride (1 mL in 3mL syringe)

Model:

NDC 61553-352-78

Lot Numbers:

190670030D (Exp. 6/9/2019)

190670031D (Exp. 6/9/2019)

190670032D (Exp. 6/9/2019)

190670033D (Exp. 6/9/2019)

190710015D (Exp. 6/11/2019)

190710016D (Exp. 6/11/2019)

190710017D (Exp. 6/11/2019)

190710018D (Exp. 6/11/2019)

190710019D (Exp. 6/11/2019)

190730028D (Exp. 6/13/2019)

190730029D (Exp. 6/13/2019)

190730030D (Exp. 6/13/2019)

190740018D (Exp. 6/16/2019)

190770028D (Exp. 6/17/2019)

190770029D (Exp. 6/17/2019)

190780027D (Exp. 6/18/2019)

190780028D (Exp. 6/18/2019)

190780029D (Exp. 6/18/2019)

190790030D (Exp. 6/19/2019)

190800012D (Exp. 6/20/2019)

190800013D (Exp. 6/20/2019)

190800014D (Exp. 6/20/2019)

190800015D (Exp. 6/20/2019)

190800016D (Exp. 6/20/2019)

190810033D (Exp. 6/23/2019)

190810034D (Exp. 6/23/2019)

190810035D (Exp. 6/23/2019)

190810036D (Exp. 6/23/2019)

190840002D (Exp. 6/24/2019)

190870008D (Exp. 6/27/2019)

190910015D (Exp. 7/1/2019)

190980033D (Exp. 7/8/2019)

190990017D (Exp. 7/9/2019)

190990030D (Exp. 7/9/2019)

191000035D (Exp. 7/10/2019)

191010008D (Exp. 7/11/2019)

191010009D (Exp. 7/11/2019)

191010010D (Exp. 7/11/2019)

191050002D (Exp. 7/15/2019)

191120002D (Exp. 7/22/2019)

191160001D (Exp. 7/28/2019)

191210020D (Exp. 7/31/2019)

191210021D (Exp. 7/31/2019)

191210022D (Exp. 7/31/2019)

191220017D (Exp. 8/1/2019)

Date Ranges: Exp. 6/9/2019 - 8/1/2019