FDA recall D-0060-2018

Product

HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17

Reason for recall

Lack Of Assurance Of Sterility.

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2017-10-19

Report date

2017-11-08

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0060-2018