The Recall Desk
HighFDA (Drugs)·D-0304-2023·Announced 2023-02-22

Methadone Syringes Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling methadone syringes due to lack of sterility assurance. The affected product was dispensed to patients 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: FDA Class II injectable drug recall for lack of sterility assurance. While no illnesses or injuries have been reported, this defect poses a real risk of contamination and infection in parenteral medications, placing it at High severity.

Plain-English summary

Sentara Infusion Services is recalling methadone syringes in 2.5MG and 4MG concentrations due to lack of sterility assurance. The affected syringes were dispensed to patients nationwide.

Lack of sterility assurance in injectable products presents a potential risk of contamination and serious infection. Patients who received these syringes should consult their healthcare provider regarding the recall and any appropriate follow-up care.

The recalled product

Product
METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Category
Drug — Injectable
Hazard
  • contamination-risk
  • sterility-failure

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 28-29
  • 2022

Distribution

Distributed nationwide across the United States.

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