HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-5...
FDA Recall #D-0296-2023 — Class II — December 27, 2022
Product Description
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 23320, NDC# 00409-2634-50
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
37 bags
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use Date: December 24-31, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated