METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home In...

FDA Recall #D-0304-2023 — Class II — December 27, 2022

Recall #D-0304-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of sterility assurance

Recalling Firm

Sentara Infusion Services — Chesapeake, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

19 syringes

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 28-29, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated