The Recall Desk
HighFDA (Drugs)·D-0296-2023·Announced 2023-02-22

Hydromorphone Infusion Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling Hydromorphone injectable solutions due to lack of sterility assurance. The recall affects 37 bags distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance in an injectable opioid medication. While no illnesses or injuries are reported in the source, the hazard presents a risk of harm to patients receiving injectable medications, and the absence of reported cases does not reduce the inherent severity of a sterility failure in a systemic drug.

Plain-English summary

Sentara Infusion Services is recalling Hydromorphone injectable solutions for pain management in various concentrations and volumes due to a lack of sterility assurance. The recalled products are Hydromorphone 1 mg/mL in normal saline (50 mL, 75 mL, 100 mL, and 175 mL) and Hydromorphone 5 mg/mL in normal saline (60 mL, 100 mL, and 250 mL).

The recall affects 37 bags that were dispensed to patients nationwide. The products have beyond-use dates of December 24–31, 2022. Hydromorphone is an opioid pain medication used with or without a Curlin pump for pain management and is available only by prescription.

Patients who have received these products should consult with their healthcare provider or pharmacist immediately. Do not use the affected medication if you have it in your possession. Return the product to your pharmacy or follow any additional instructions provided by your healthcare provider.

The recalled product

Product
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23
Manufacturer
Sentara Infusion Services
Category
Drug — Injectable Opioid
Hazard
  • lack-of-sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Beyond Use Date: December 24-31
  • 2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category