PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: February 22, 2023 Initiated: December 27, 2022 #D-0296-2023

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

Details

Recalling Firm
Sentara Infusion Services
Units Affected
37 bags
Distribution
Dispensed to Patients Nationwide.
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Sentara Infusion Services. Units affected: 37 bags.
Why was this product recalled?
Lack of sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0296-2023.