FDA recall D-1084-2020

Product

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

Reason for recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-04-15

Termination date

2025-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1084-2020